Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 260

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 260
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                                            and/or reputation, and subject us to significant fines and liability.

●We
                                            are exposed to fluctuations in exchange rates which may adversely affect our operating results.

Risks
Related to Intellectual Property

●Our
                                            success depends on our ability to protect our intellectual property and our proprietary technology,
                                            and we may not be able to protect our intellectual property rights throughout the world.

●If we are unable to obtain and maintain patent protection for any drug
candidates, our competitors could develop and commercialize products or technology similar or identical to ours, and our ability to successfully
commercialize any drug candidates we may develop, and our technology may be adversely affected. We are currently exploring a patent protection
strategy for our candidate PSX-001. If these efforts are unsuccessful, we may not be able to obtain intellectual property protection for
this candidate.

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.

●Our
                                            common stock could be further diluted as the result of the issuance of additional shares
                                            of common stock, warrants, options or other convertible securities. Future sales of shares
                                            of our common stock in the public market, or the perception that such sales could occur,
                                            has in the past and could in the future cause our stock price to fall.

 ●We are and may continue to be subject to short-selling strategies.

41

Risks
Related to Our Financial Condition and Capital Requirements

We
have a history of operating losses and may not achieve or maintain profitability in the future. Our ability to achieve profitability
depends on the successful development of our drug candidates.

We are a clinical-stage biopharmaceutical company,
and the success of our drug candidates is therefore uncertain. None of our drug candidates has been approved for commercial sale in any
jurisdiction, and we expect it to be several years before any of them may be approved, if ever. We will not be able to generate product
revenue unless and until our drug candidates, alone or with future partners, successfully complete clinical trials, receive regulatory
approval and are successfully commercialized. Although we have entered into a joint venture with respect to PSX-001 and may again seek
to obtain revenue from collaboration or licensing agreements with third parties, these agreements and joint ventures may not provide us
with material or ongoing revenues.

We have experienced significant recurring operating