Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 134

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 134
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 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
suppliers and seek and obtain necessary regulatory approvals. If this occurs, we will be unable to satisfy manufacturing needs on a timely
basis, if at all. If changes to CMOs occur, then there also may be changes to manufacturing processes inherent in the setup of new operations
for our drug candidates and any of our drugs that may obtain approval. Any such changes could require the conduct of bridging studies
and regulatory approval before we can use any materials produced at new facilities or under new processes in clinical trials or, for
any candidates reaching approval, in our commercial supply. For these reasons, a significant disruptive event of any CMOs could have
drastic consequences, including placing our ability to continue operations at risk.

50

If
our third-party manufacturers fail to provide supplies of our drugs or drug candidates when and as needed for any reason, our business,
results of operations and prospects may be materially and adversely harmed.

We
rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our
business could be substantially harmed.

We
are, and may continue to be, reliant on other parties for the successful development and commercialization of many of our drug candidates.
We rely upon CROs and clinical investigators for the conduct of our clinical trials and may rely upon contract laboratories for execution
of our preclinical studies, and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that
each of our studies and trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards,
and our reliance on the CROs or collaboration partners does not relieve us of our regulatory responsibilities