Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 149

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 149
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 conduct additional clinical trials that compare the cost-effectiveness of our drug candidates to other available therapies in order
to obtain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure
on prices or reimbursement levels within the country of publication and other countries. If reimbursement of our products is unavailable
or limited in scope or amount in a particular country, or if pricing is set at unsatisfactory levels, we may be unable to successfully
commercialize and achieve or sustain profitability for sales of any of our drug candidates that are approved for marketing in that country
and our business could be adversely affected.

We could become exposed to product liability claims that could
adversely affect our business.

The testing, marketing and sale of therapeutic
products entails an inherent risk of product liability. We rely on a number of third-party researchers and contractors to produce, collect,
and analyze data regarding the safety and efficacy of our drug candidates.

Notwithstanding our control procedures, we may
face product liability exposure related to the testing of our drug candidates in human clinical trials. If any of our drug candidates
are approved for sale, we may face exposure to claims by an even greater number of people than were involved in the clinical trials once
marketing, distribution and sales of our drug candidates begin. Regardless of merit or eventual outcome, liability claims may result in:

●decreased demand for our drug candidates;

●injury to our reputation;

●withdrawal of clinical trial participants;

●costs of related litigation;

●substantial monetary awards to patients and others;

●loss of revenues; and

●the inability to commercialize drug candidates.

With respect to product liability claims, we could
face additional liability beyond insurance limits if testing mistakes were to endanger any human subjects. In addition, if a claim is
made against us in conjunction with these research testing activities, the market price of our shares of common stock may be negatively
affected.

Product shipment delays could have a material adverse effect
on our business, results of operations and financial condition.

The shipment, import and export of our drug candidates
and the APIs used to manufacture them, along with the drugs used in our psychedelic-assisted psychotherapy services, will require import
and export licenses. In the United States, the FDA, U.S. Customs and Border Protection, and the DEA; in Canada, the Canada Border Services
Agency, Health Canada; in Europe, the EMA and the European Commission; in Australia and New Zealand, the Australian Customs and Board