Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 277

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 277
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pliers 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. We also rely on third
parties to assist in conducting our nonclinical studies in accordance with GLP and requirements with respect to animal welfare. We and
our CROs or collaboration or licensing partners are required to comply with GCP, which are regulations and guidelines enforced by the
FDA, EMA, MHRA and comparable international regulatory authorities for all of our products in clinical development. Regulatory authorities
enforce GCP regulations, and other regulations applicable to clinical trials and investigational drug products, through periodic inspections
of trial sponsors, CROs, principal investigators and trial sites. If we or any of our CROs or partners fail to comply with applicable
GCP regulations or other clinical trial regulations