Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 296

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 296
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candidates will likely be determined to have a high potential for abuse and therefore required to be administered at our trial sites,
which could limit commercial updates. Furthermore, state and federal enforcement actions, regulatory requirements and legislation intended
to reduce prescription drug abuse, such as the requirement that physicians consult a state prescription drug monitoring program, may make
physicians less willing to prescribe, and pharmacies to dispense, Schedule II products.

In May 2024, the DEA published a notice of proposed
rulemaking to reschedule marijuana (the cannabis plant and the various compounds, manufactures, salts, derivatives, mixtures, or preparations
from it) from Schedule I to Schedule III. And in August 2025, the DEA forwarded to HHS a citizen petition proposing that the agencies
reschedule psilocybin from Schedule I to Schedule II. HHS will conduct a scientific and medical review of the proposed rescheduling and
supporting data and, once completed, will issue a recommendation to the DEA. Even if a final rule rescheduling is implemented in either
case, we, our third-party manufacturers, and our other partners must still comply with all CSA requirements and DEA regulations applicable
to the rescheduled controlled substances with respect to our product drug candidates.

We currently source APIs from Taiwan, India and
the United States and our finished drug candidates are currently being manufactured in Colombia and the United States. In addition, we
may decide to develop, manufacture or commercialize our drug candidates in additional countries. As a result, we will also be subject
to controlled substance laws and regulations from the TGA in Australia and from other regulatory agencies in other countries where we
develop, manufacture or commercialize our drug candidates in the future.

60

Other countries may have different laws and regulations
with which we will be required to comply. For example, EU legislation does not establish different classes of narcotic or psychotropic
substances. However, the United Nations (“UN”), Single Convention on Narcotic Drugs of 1961 and the UN Convention on Psychotropic
Substances of 1971 (collectively, the “UN Conventions”) codify internationally applicable control measures to ensure the availability
of narcotic drugs and psychotropic substances for medical and scientific purposes. The individual EU member states are all signatories
to these UN Conventions. All signatories have a dual obligation to ensure that these substances are available for medical purposes and
to protect populations against abuse and dependence. The UN Conventions regulate narcotic drugs and psychotropic substances as Schedule