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 classification, 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 classification.

“We welcome this development in the United States,” said Elliot McKerr, Chief Executive Officer of HYTN. “The executive order reflects 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 Certificate of GMP Conformity applicable to the United States, reflecting compliance with recognized Good Manufacturing Practices.

In addition to its DEL, HYTN holds a Cannabis Drug Licence (CDL), which is issued to qualified 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 reclassification 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 finished 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 specifications and regulatory requirements; and that the Company will be able to obtain, maintain, or renew required licenses, certifications, 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 reclassification of cannabis to Schedule III, or that such reclassification is delayed, modified, 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 insufficient 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 certifications on anticipated terms or at all; regulatory risks; operational risks; and financing, 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 Officer
1.866.590.9289

HYTN Investor Relations:
1.866.590.9289
investments@hytn.life

The Canadian Securities Exchange has not reviewed, approved, or disapproved the contents of this ‎press release.‎