Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 140

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 140
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We
have conducted, and intend to conduct, clinical trials for certain of our drug candidates at sites outside of the United States, and
the U.S. regulatory agencies may not accept data from trials conducted in such locations.

As
noted above, we have conducted trials for our drug candidates pursuant to Australian law and intend to conduct future and current trials
for these candidates pursuant to FDA regulations in an effort to obtain FDA approval. The FDA’s acceptance of data from clinical
trials conducted outside the United States may be subject to certain conditions or may not be accepted at all, and other comparable non-U.S.
regulatory authorities may have similar restrictions and conditions with respect to clinical trials conducted outside of their respective
jurisdictions. In cases where data from clinical trials conducted wholly outside of the United States are intended to serve as the basis
for marketing approval in the United States, the FDA will generally not accept such non-U.S. trial data unless (i) the data are determined
to be applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized
competence and pursuant to GCP regulations; and (iii) the FDA is able to validate the data through an onsite inspection or other appropriate
means, if necessary. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and
statistical powering, must be met. Furthermore, even where the non-U.S. trial data are not intended to serve as the sole basis for approval,
the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted
in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
Many comparable non-U.S. regulatory authorities have similar approval requirements.

In
addition, while these clinical trials are subject to the applicable local laws, the FDA acceptance of the data will be dependent upon
its determination that the trials also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA
will accept future data from trials conducted outside of the United States. If the FDA does not accept the data from any of our clinical
trials that we determine to conduct or have conducted outside the United States, it would likely result in the need for additional trials
that would be costly and time-consuming and delay or permanently halt the development of a drug candidate.

Conducting
clinical trials outside the United States