Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 125

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 125
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 could have an impact on our share trading prices, increase
the volatility of the price of our common stock, or reduce our available cash balance such that we will be required to seek financing
to support our operations. Our share repurchase program may be modified, suspended, or terminated at any time, which may result
in a decrease in the trading prices of our common stock. Even if our share repurchase program is fully implemented, it may not
enhance long-term stockholder value. Additionally, repurchases are subject to the 1% share repurchase excise tax enacted by the IRA, which
may be offset by shares newly issued during that fiscal year. We have and will continue to 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