Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 408

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1B
Chunk 408
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 to the extent our development activities are successful.
At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the
preclinical and clinical development of our drug candidates. Our R&D expenses have varied, and our future R&D expenses may vary,
significantly based on a wide variety of factors such as:

●the number and scope, rate of progress, expense and results of
                                            our clinical trials and preclinical studies, including any modifications to clinical development
                                            plans based on feedback that we may receive from regulatory authorities;

●per patient trial costs;

●the number of trials required for approval;

●the number of sites included in the trials;

●the countries in which the trials are conducted;

●the length of time required to enroll eligible patients;

●the number of patients that participate in the trials;

●the number of doses that patients receive;

●the drop-out or discontinuation rates of patients;

●the potential additional safety monitoring requested by regulatory
                                            agencies;

●the duration of patient participation in the trials and follow-up;

●the cost and timing of manufacturing of our drug candidates;

●the costs, if any, of obtaining third-party drugs for use in
                                            our combination trials;

●the extent of changes in government regulation and regulatory
                                            guidance;

●the efficacy and safety profile of our drug candidates;

●the timing, receipt, and terms of any approvals from applicable
                                            regulatory authorities; and

●the extent to which we establish additional collaboration, license,
                                            or other arrangements.

86

A change in the outcome of any of these variables
with respect to the development of our drug candidates could significantly change the costs and timing associated with the development
of that drug candidate. We may never succeed in obtaining regulatory approval for any drug candidate.

In addition, we are obligated under our contracts
with CROs to reimburse these CROs for certain expenses incurred by them in the performance of the services they provide to us. The precise
timing and amounts of these expenses and our corresponding reimbursement obligations are and may continue to be uncertain and outside
of our control. We incur the costs for these reimbursement obligations when invoiced by the CRO. We often receive invoices long after
the CRO has performed the services that are the subject of the invoice. As a result, our related operating expenses have and may continue
to vary significantly period-to-period and are not necessarily indicative of the expenses associated with the activities of the CRO conducted
during the period covered