Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 278

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 278
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, the data generated in our clinical trials may be deemed unreliable and the FDA,
EMA, MHPA or comparable international regulatory authorities may require us to perform additional clinical trials before approving our
marketing applications. We cannot provide assurance that upon inspection by a given regulatory authority that such regulatory authority
will determine that any of our clinical trials comply with GCP requirements or other applicable regulations. In addition, our clinical
trials must be conducted with product manufactured under cGMP requirements. Failure to comply with these regulations may require us to
repeat nonclinical studies and clinical trials, which would delay the regulatory approval process.

Our
CROs and other contractors or collaborators are not our employees, and except for remedies available to us under such agreements with
such CROs, we cannot control whether or not they devote sufficient time and resources to our on-going or future clinical or nonclinical
programs, as applicable. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines or
if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory
requirements or for other reasons, then our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory
approval for or successfully commercialize our drug candidates. As a result, our results of operations and the commercial prospects for
our drug candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed.

If
any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties
on commercially reasonable terms, or at all. Entering into arrangements with alternative CROs, clinical trial investigators or other
third parties involves additional cost and requires management focus and time, in addition to requiring a transition period when a new
CRO, clinical trial investigator or other third party begins work. If third parties do not successfully carry out their contractual duties
or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain
are compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, any clinical trials
such third parties are associated with may be extended, delayed or terminated, and we may not be able to obtain marketing approval for
or successfully commercialize our drug candidates. As a result, we believe that our financial results and the commercial prospects for
our drug candidates in the subject indication would be harmed, our