Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 127

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 127
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 in obtaining authorization to commence a trial, including approval from the appropriate
                                            IRB to conduct testing of a candidate on human subjects, or inability to comply with conditions
                                            imposed by a regulatory authority regarding the scope or design of a clinical trial;

●delay
                                            in reaching, or failure to reach, agreement on acceptable terms with prospective CROs, and
                                            clinical trial sites, the terms of which can be subject to extensive negotiation and may
                                            vary significantly among different CROs and trial sites;

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●inability,
                                            delay or failure in identifying and maintaining a sufficient number of trial sites, many
                                            of which may already be engaged in other clinical programs;

●delay
                                            or failure in recruiting and enrolling suitable volunteers or patients to participate in
                                            a trial such as occurred in our prior trial investigating IHL-675A;

●delay
                                            or failure in developing and validating companion diagnostics, if they are deemed necessary,
                                            on a timely basis;

●failure
                                            of trial participants to complete a trial or return for post-treatment follow-up;

●inability
                                            to monitor trial participants adequately during or after treatment;

●clinical
                                            sites and investigators deviating from trial protocols, failing to conduct the trial in accordance
                                            with regulatory requirements or dropping out of a trial;

●failure
                                            to initiate or delay of or inability to complete a clinical trial as a result of a clinical
                                            hold imposed by the FDA or comparable international regulatory authority due to observed
                                            safety findings or other reasons;

●negative
                                            or inconclusive results in our clinical trials, and our decision to or regulators’
                                            requirement that we conduct additional non-clinical studies, clinical trials or that we abandon
                                            one or more of our product development programs; or

●inability
                                            to manufacture sufficient quantities of a drug candidate of acceptable quality for use in
                                            clinical trials.

We rely and plan to continue to rely on third-party
CROs, CMOs and clinical trial sites to ensure the proper and timely conduct of our clinical trials. Although we have and expect that we
will continue to have agreements in place with CROs and CMOs governing their contracted activities and conduct, we have limited influence
over their actual performance. As a result, we ultimately do not and will not have control over a CRO’s or CMO’s compliance
with the terms of any agreement it may have with us, its compliance with applicable regulatory requirements or its adherence to agreed-upon