Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 71

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 71
---
 candidate’s chemical
and biological activities, formulation and stability, as well as studies to evaluate toxicity and potential for other adverse events,
which support subsequent clinical testing and rationale for therapeutic use.

The Consolidated Appropriations Act for 2023, signed
into law on December 29, 2022, (P.L. 117-328) amended both the FDCA and Public Health Service Act to specify that nonclinical testing
for drugs and biologics, respectively, may, but is not required to, include in vivo animal testing. According to the amended language,
a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays, organ chips,
or microphysiological systems), in silico studies (i.e., computer modeling), other human or non-human biology-based tests (e.g.,
bioprinting), or in vivo animal tests.

The results of preclinical tests, together with
manufacturing information and analytical data, are submitted as part of an IND to the FDA. An IND is a request for authorization from
the FDA to administer an investigational product to humans and must become effective before human clinical trials may begin. A 30-day
waiting period after the submission of each IND is required before commencement of clinical testing in humans. An IND automatically becomes
effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed
clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding
concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to
commence. Clinical holds may also be imposed by the FDA at any time before or during clinical trials due to safety concerns or non-compliance.

A clinical trial involves the administration of
the investigational drug candidate to patients under the supervision of qualified investigators following GCP standards, which include
the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial (unless
the consent requirement has been waived by an IRB) along with the requirement to ensure that the data and results reported from the clinical
trials are credible and accurate. GCP requirements are meant to protect the rights and health of patients and to define the roles of clinical
trial sponsors, administrators and monitors. A clinical trial is conducted under a protocol that details, among other things, the objectives
of