Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 268

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 268
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 take the share repurchase excise tax into account
with respect to our decisions to repurchase shares.

45

Risks
Related to the Development and Regulatory Approval of Our Drug Candidates

If
we do not obtain the necessary regulatory approvals, we will be unable to commercialize our drug candidates.

We are not permitted to market our drug candidates
in the United States until we receive FDA approval of an NDA, or in any other jurisdiction until we receive the requisite approval from
the respective regulatory authorities in such jurisdictions. The time required to obtain FDA and other approvals is unpredictable but
typically takes many years following the commencement of clinical trials, depending upon the type, complexity and novelty of the drug
candidate. The standards that the FDA and its international counterparts use when regulating companies such as ours are not always applied
predictably or uniformly and can change. Any analysis we perform of data from chemistry, manufacturing and controls, preclinical and clinical
activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.
We may also again encounter unexpected delays or increased costs due to new government regulations, for example, from future legislation
or administrative action, or from changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.
It is impossible to predict whether legislative changes will be enacted, or whether FDA or international regulations, guidance or interpretations
will be changed, or what the impact of such changes, if any, may be. Any delay or failure in obtaining required approvals could adversely
affect our ability to generate revenues from the particular drug candidate for which we are seeking approval.

Furthermore,
obtaining and maintaining regulatory approval of our drug candidates in one jurisdiction does not guarantee that we will be able to obtain
or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction
may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a
drug candidate, similar international regulatory authorities must also approve the manufacturing, marketing and promotion of the drug
candidate in those countries. Approval and licensure procedures vary among jurisdictions and can involve requirements and administrative
review periods different from, and greater than, those in the United States, including additional nonclinical studies or clinical trials
as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions
outside the United States, a drug candidate must be approved for reimbursement before it can be approved for sale in that