Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 259

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 259
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 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
Related to Our Business Operations

●Our
                                            R&D efforts will be jeopardized if we are unable to retain key personnel and cultivate
                                            key academic and scientific collaborations.

●Our
                                            business is subject to complex and evolving U.S. federal and state, and international laws
                                            and regulations, imposing obligations on how we collect, use, disclose, store and process
                                            personal data. We are also subject to information security policies and contractual obligations
                                            relating to privacy and data protection, including the use, processing, and cross-border
                                            transfer of personal data. The actual or perceived failure by us or vendors to comply with
                                            these laws and regulations, policies and contractual obligations could harm our business