Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 270

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 270
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 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
time schedules and deadlines, and a future CRO’s or CMO’s failure to perform those obligations could subject any of our clinical
trials to delays or failure.

Further,
we may also again encounter delays if a clinical trial is suspended or terminated by us, by any IRB or ethics committee, or by the FDA,
EMA, MHRA, or other regulatory authority. A suspension or termination may occur due to a number of factors, including failure to conduct
the clinical trial in accordance with regulatory requirements, inspection of the clinical trial operations or trial site by the FDA,
EMA, MHRA or other regulatory authorities, exposing participants to health risks caused by unforeseen safety issues or adverse side effects,
development of previously