Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 330

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 330
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 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 may be influenced by many factors, including:

●our ability to obtain regulatory approvals for IHL-42X, PSX-001,
                                            and IHL-675A, or other drug candidates, and delays or failures to obtain such approvals;

●adverse results, clinical holds, or delays in the clinical trials
                                            of our drug candidates or any future clinical trials we may conduct, or changes in the development
                                            status of our drug candidates;

●failure of any of our drug candidates, if approved, to achieve
                                            commercial success;

●negative publicity or public perception of the use of cannabinoid
                                            or psychedelic substances as a medical treatment;

●failure to maintain our existing third-party collaboration, license