Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 116

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 116
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 candidates. If we are unable to raise capital when needed or to do so on terms that
                                            are favorable to us, we could be forced to again delay, reduce or eliminate our development
                                            programs or commercialization efforts or reduce or scale back our operations.

 ●We may be unable to maintain the listing of our shares of common stock
on the Nasdaq Capital Market.

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.

●Clinical
                                            drug development involves a lengthy and expensive process with uncertain outcomes. The results
                                            of earlier preclinical studies or trials may not be predictive of the results of later clinical
                                            trials. Clinical trials are difficult to design and implement, and any of our clinical trials
                                            could produce unsuccessful results or fail at any stage in the process.

●Topline,
                                            interim or preliminary data from our trials may not be representative of final results.

●We
                                            rely on third parties to conduct our preclinical and clinical trials. If these third parties
                                            do not successfully carry out their contractual duties or meet expected deadlines, we may
                                            not be able to obtain regulatory approval for or commercialize our drug candidates and our
                                            business could be substantially harmed.

40

Risks
Related to Commercialization of Our Drug Candidates

●Even
                                            if we receive marketing approval of a drug candidate, we will be subject to ongoing regulatory
                                            obligations and continued regulatory review, which may result in significant additional expense
                                            and we may be subject to penalties if we fail to comply with regulatory requirements or experience
                                            unanticipated problems with our products, if approved.

●Our
                                            drug candidates will be subject to controlled substance laws and regulations. Failure to
                                            receive necessary approvals may delay the launch of our drug candidates and failure to comply
                                            with these laws and regulations may adversely affect the results of our business operations.

●The
                                            production and sale of our drug candidates may be considered illegal or may otherwise be
                                            restricted due to the use of controlled substances, which may have consequences for the legality
                                            of investments from international jurisdictions.

 ●The markets for the target indications for our drug candidates are
competitive and certain of our competitors have more advanced candidates in their respective pipelines. While we believe our drug candidates
have expected benefits that may overcome these advantages, our efforts to prevail as compared to our competitors may not be successful.

Risks