Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 68

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 68
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gen Inc., Novartis AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company,
F. Hoffmann-La Roche AG, Bristol Myers Squibb, AstraZeneca PLC, and Merck & Co., Inc. While we believe we have identified the potential
for IHL-675A to more effectively reduce pain and increase quality of life in addition to or over these existing therapies and standard
of care, IHL-675A will compete with or complement these other therapeutic options.

13

We are further aware that
there are non-FDA approved cannabinoid preparations being made available from companies in the medical marijuana industry, which might
compete with our drug candidates. While federal law prohibits the sale and distribution of most marijuana products not approved or authorized
by FDA, the vast majority of states and the District of Columbia have legalized either cannabinoids or marijuana for either recreational
or medical use, or both, and congressional efforts related to legalization of marijuana continue. Further, under the U.S. Farm Bill, enacted
in late 2018, certain extracts and other material derived from cannabis are no longer controlled under the federal Controlled Substances
Act of 1970 (“CSA”). However, the marketing of such products as a food, dietary supplement, or for medical purposes remains
subject to FDA requirements. With respect to the marketing of CBD as a food or dietary supplement, in January 2023, the FDA concluded
that the existing regulatory frameworks for foods and supplements were not appropriate for CBD products and denied three citizen petitions
that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. In addition, following
receipt of a scientific and medical evaluation of marijuana from the Department of Health and Human Services (“HHS”) recommending
that the substance be moved from Schedule I to Schedule III, the U.S. Drug Enforcement Administration (“DEA”) issued a notice
of proposed rulemaking in May 2024 to effectuate such rescheduling. The public comment period on the proposed rule ended in mid-2024 and
a public hearing on the proposal was scheduled by DEA for January 2025. The DEA hearing was postponed indefinitely by the presiding administrative
law judge, and as of September 2025, the rulemaking appears stalled and marijuana remains a Schedule I substance. However, President Trump
has expressed interest in rescheduling marijuana and his administration is continuing to evaluate the Schedule III proposal. Although
our business is distinct from that of entities marketing FDA-un