Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 187

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 187
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 be no assurance that any such patent applications will issue as granted patents,
and even if they do issue, such patent claims may be insufficient to prevent third parties, such as our competitors, from utilizing our
technology. Any failure to obtain or maintain patent protection with respect to our and drug candidates could have a material adverse
effect on our business, financial condition, results of operations, and prospects.

Price controls may be imposed in non-U.S. markets, which may
negatively affect our future profitability.

In some countries, particularly EU member states,
Japan, Australia and Canada, the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations
with governmental authorities can take considerable time after receipt of marketing approval for a product. In addition, there can be
considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment
measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue
after reimbursement has been obtained. Reference pricing used by various EU member states and parallel distribution, or arbitrage between
low-priced and high-priced member states, can further reduce prices. In some countries, we or our collaborators may be required to conduct
a clinical trial or other studies that compare the cost-effectiveness of our drug candidates to other available therapies in order to
obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further
pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of our drug candidates
is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business, revenues or profitability
could be harmed.

76

Risks Related to Investing in Our Securities

The price of our common stock has been and may continue to be
highly volatile, which may make it difficult for stockholders to sell our common stock when desired or at attractive prices.

Following our redomiciliation, the trading price
of our common stock has been volatile and could be subject to fluctuations in response to various factors, some of which are beyond our
control. Factors such as announcements of variations in our quarterly financial results and fluctuations in revenue could also cause
the market price of our common stock to fluctuate. In addition, the stock market in general and the market for biopharmaceutical companies
in particular, have experienced extreme volatility that has often been unrelated to companies operating performance. The market price
for our common stock