HYTN Welcomes U.S.Executive Order Initiating Cannabis Reclassification to Schedule III
Source: HYTN Innovations Inc.
December 18, 2025 17:01 ET
HYTN Welcomes U.S.
Executive Order Initiating
Cannabis Reclassification to
Schedule III
VANCOUVER, British Columbia, Dec. 18, 2025 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE:
HYTN, FSE: 85W0, OTC PINK: HYTNF) (“HYTN” or the “Company”), a pharmaceutical-grade cannabis
manufacturer, acknowledges the announcement by the United States administration issuing an
executive order directing federal agencies to initiate the reclassification of cannabis to a Schedule
III controlled substance under U.S. federal law.
The executive order directs the relevant federal authorities to advance the administrative process
required to move cannabis from Schedule I to Schedule III under the U.S. Controlled Substances
Act. A Schedule III classification would place cannabis within the same federal drug schedule as
substances such as acetaminophen with codeine, testosterone, and certain anabolic steroids,
recognizing accepted medical use while maintaining regulatory controls. If implemented through
the applicable regulatory processes, this change would establish a framework under which
cannabis may be regulated as a controlled pharmaceutical product, rather than solely within state-
level recreational or medical cannabis regimes.
Under a Schedule III classication, cannabis products intended for medical use would be expected
to fall under the oversight of the U.S. Food and Drug Administration (FDA) and the Drug
Enforcement Administration (DEA), and to be subject to applicable federal requirements governing
manufacturing, handling, research, prescribing, and importation. These requirements would differ
materially from the existing state-by-state frameworks that currently permit the sale of cannabis
products despite its current federal classication.
“We welcome this development in the United States,” said Elliot McKerr, Chief Executive Ofcer of
HYTN. “The executive order reects a more structured and controlled regulatory approach toward
cannabis that is aligned with established pharmaceutical frameworks. As regulatory expectations
evolve, HYTN has focused on building systems, infrastructure, and quality standards consistent with
GMP-based drug manufacturing. We look forward to assessing how this process may shape future
regulatory and commercial pathways.”
The Company notes that it currently holds a Health Canada Drug Establishment Licence (DEL) for
non-sterile pharmaceutical manufacturing and has received a Certicate of GMP Conformity
applicable to the United States, reecting compliance with recognized Good Manufacturing
Practices.
In addition to its DEL, HYTN holds a Cannabis Drug Licence (CDL), which is issued to qualied DEL
holders authorized to manufacture cannabis-derived pharmaceutical products. The Company also
maintains an established GMP platform, including stability programs and international export
operations supplying regulated medical markets in the United Kingdom, Germany, and Australia.
HYTN believes these capabilities position it to evaluate potential opportunities that may emerge as
the Schedule III regulatory process advances.
About HYTN Innovations Inc.
HYTN Innovations Inc. is a pharmaceutical company specializing in the formulation, manufacturing,
marketing, and sale of products containing psychoactive and psychotropic compounds, including
cannabis-derived cannabinoids. HYTN is dedicated to becoming a premier provider of these
products across all federally regulated markets. The Company accomplishes this by strategically
identifying market opportunities and effectively bringing innovative products to market through its
advanced development platform.
About Cannabis Drug Licenses (CDL)
A CDL is issued by Health Canada under the Food and Drug Regulations and authorizes the
possession, production, packaging, labelling, and distribution of cannabis when used as an active
ingredient in pharmaceutical drug products. The CDL is required for any company intending to
manufacture prescription drugs containing cannabis for human use. It can only be obtained by
holders of a DEL and must meet the same regulatory standards applied to conventional
pharmaceutical manufacturers, including compliance with GMP.
About Good Manufacturing Practices (GMP)
GMP guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that
a manufactured product is safe for human consumption or use. Many countries have legislated that
manufacturers follow GMP procedures and create their own GMP guidelines that correspond with
their legislation.
FORWARD-LOOKING STATEMENTS
Certain statements contained in this press release constitute forward-looking information within
the meaning of applicable securities laws. Forward-looking information relates to future events or
future performance and is generally identifiable by the use of words such as “could,” “may,”
“intend,” “expect,” “believe,” “will,” “project,” “estimate,” “anticipate,” and similar expressions, or
statements regarding matters that are not historical facts. Such statements are based on the
Company’s current beliefs, assumptions, and expectations regarding future events and operating
conditions.
This press release contains forward-looking information relating to, among other things: the
potential regulatory outcomes arising from the executive order issued by the United States
administration directing federal agencies to initiate the reclassication of cannabis under the U.S.
Controlled Substances Act; the potential development, timing, scope, or implementation of any
Schedule III regulatory framework in the United States; the Company’s potential participation in
the manufacturing, packaging, labelling, and distribution of cannabis-derived pharmaceutical
products, including cannabis-based active pharmaceutical ingredients and nished
pharmaceutical formulations; the Company’s ability to produce such products in compliance with
applicable regulatory requirements; the Company’s potential participation in the supply chain for
cannabinoid-based therapeutics; and the anticipated impact, if any, of such developments on the
Company.
Forward-looking information is based on certain assumptions, including, but not limited to: the
assumption that the executive order may result in further regulatory actions by U.S. federal
authorities; that any such actions may lead to changes in the regulatory treatment of cannabis for
medical or pharmaceutical purposes; that the Company may be able to establish commercial
relationships with pharmaceutical sponsors, biotechnology companies, distributors, pharmacies,
government entities, and other participants in the cannabinoid-based pharmaceutical industry;
that such counterparties may have demand for the Company’s products or services; that the
Company will be able to meet applicable product specications and regulatory requirements; and
that the Company will be able to obtain, maintain, or renew required licenses, certications, and
regulatory authorizations on acceptable terms or at all. These assumptions are based on
information currently available to the Company. Although management believes such
assumptions to be reasonable, there can be no assurance that they will prove to be correct.
Forward-looking information is subject to known and unknown risks, uncertainties, and other
factors that may cause actual results, performance, or achievements to differ materially from those
expressed or implied by such forward-looking information. These risks and uncertainties include,
without limitation: the risk that the executive order does not result in a completed reclassication
of cannabis to Schedule III, or that such reclassication is delayed, modied, or not implemented as
anticipated; the risk that regulatory requirements applicable to Schedule III substances may limit
or restrict the Company’s ability to participate in U.S. markets; the risk that the Company may be
unable to establish commercial relationships within the cannabinoid-based pharmaceutical
industry; the risk of insufcient demand for the Company’s products or services; the risk that the
Company may be unable to manufacture products that meet regulatory or commercial
requirements; the risk that the Company may not obtain or maintain required licenses, approvals,
or certications on anticipated terms or at all; regulatory risks; operational risks; and nancing,
capitalization, and liquidity risks.
The forward-looking information contained in this press release is made as of the date hereof, and
the Company does not undertake any obligation to update or revise any forward-looking
information, whether as a result of new information, future events, or otherwise, except as required
by applicable securities laws. Readers are cautioned not to place undue reliance on forward-
looking information.
Elliot McKerr
Chief Executive Ofcer
1.866.590.9289
HYTN Investor Relations:
1.866.590.9289
The Canadian Securities Exchange has not reviewed, approved, or disapproved the contents of
this press release.
