Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 273

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 273
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 studies. We will be required to demonstrate
with substantial evidence through well-controlled clinical trials that our drug candidates are safe and effective for use in a diverse
population before we can seek marketing approvals for their commercial sale in any jurisdiction. Phase 1 and Phase 2 clinical trials
are not primarily designed to test the efficacy of a drug candidate, but rather to test safety and to understand the drug candidate’s
side effects at various doses and schedules. Further, Phase 3 clinical trials may not show sufficient safety or efficacy to obtain regulatory
approval for marketing. In addition, clinical results are frequently susceptible to varying interpretations that may delay, limit or
prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could require that the
clinical trial be redone or terminated. The length of time necessary to complete clinical trials and to submit an application for marketing
approval by applicable regulatory authorities may also vary significantly based on the type, complexity and novelty of the drug candidate
involved, as well as other factors. If we suffer any additional significant delays, quality issues, setbacks or negative results in,
or termination of, our clinical trials, we may be unable to continue the development of our drug candidates or generate revenue and our
business may be severely harmed.

48

Our
drug candidates may cause undesirable side effects that could delay or prevent their marketing approval, limit their commercial potential,
or result in significant negative consequences following marketing approval, if marketing approval is obtained.

Undesirable
side effects caused by our drug candidates could cause us or the FDA, EMA, MHRA or other regulatory authorities to interrupt, delay or
halt our clinical trials and could result in a more restrictive label or the delay or denial of marketing approval by the FDA or other
regulatory authorities of our drug candidates. In the event that our clinical trials produce undesirable side effects, our trials could
be suspended or terminated and the FDA, EMA or MHRA or comparable international regulatory authorities could order us to cease further
development of or deny approval of our drug candidates for any or all targeted indications. In addition to this, any drug-candidate-related
side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product
liability claims.

Clinical
trials by their nature utilize a sample of the potential patient population. With a limited number of patients, rare and severe side
effects of our drug candidates may only be uncovered with a significantly larger number of patients exposed to the drug candidate. If
our