Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 130

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 130
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. Delays or failures in planned enrollment or retention of clinical trial subjects may again result
in increased costs or program delays, which could have a harmful effect on our ability to develop a drug candidate or could render further
development impossible.

The
ongoing and future clinical trials of our drug candidates may not show sufficient safety and efficacy to obtain requisite regulatory
approvals for commercial sale.

We
currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. Failure can occur at
any stage of clinical development. Clinical trials may produce negative or inconclusive results, and we or any future collaborators may
decide, or regulators may require us, to conduct additional clinical trials or nonclinical 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