HYTN Secures Cannabis Drug Licence, Advancing Prescription Drug Pathway for Cannabinoid-Based Medicines

Rhea-AI Summary

HYTN Innovations (OTC:HYTNF) has secured a Cannabis Drug Licence (CDL) from Health Canada on July 2, 2025, marking a significant expansion of its pharmaceutical manufacturing capabilities. This licence complements HYTN's existing Drug Establishment Licence (DEL) and cannabis licences, positioning the company to manufacture cannabis-derived pharmaceutical drugs.

As a GMP-certified manufacturer, HYTN can now support clinical research, pursue drug approvals, and develop prescription pharmaceutical products. The company is also progressing with EudraGMDP registration for European markets and can serve as a Contract Development and Manufacturing Organization (CDMO) partner for clinical-stage companies.

The market potential is demonstrated by Epidiolex, a CBD-derived prescription drug that generated $972.4 million in sales in 2024 with an 88.2% gross margin.

Positive

• Obtained Cannabis Drug Licence enabling prescription drug development and manufacturing
• Strategic positioning as one of few companies authorized for cannabis-derived pharmaceutical production in Canada
• Ability to serve both regulated cannabis and pharmaceutical markets with GMP certification
• Potential to tap into high-margin pharmaceutical market (reference: Epidiolex's 88.2% gross margin)

Negative

• Limited access to GMP-compliant cannabis-derived APIs due to high regulatory standards
• Significant operational and regulatory requirements for pharmaceutical supply chain participation

VANCOUVER, British Columbia, July 14, 2025 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) (“HYTN” or the “Company”), a leader in pharmaceutical-grade cannabis manufacturing, is pleased to announce it has received a Cannabis Drug Licence (CDL) from Health Canada. The CDL, issued July 2, 2025, complements HYTN’s existing Drug Establishment Licence (DEL) and federally issued Cannabis Licences, placing the Company among a limited group of organizations authorized to manufacture cannabis-derived pharmaceutical drugs in Canada.

As an existing Good Manufacturing Practices (GMP)-certified manufacturer, HYTN currently services international markets with cannabinoid products under GMP-cannabis frameworks. The newly issued CDL provides new and distinct regulatory pathways to the Company, enabling the fabrication, packaging, labelling, and distribution of prescription pharmaceutical products (Rx). This advancement permits HYTN to support clinical research, generate regulatory data, and pursue future drug approvals and market authorisations.

“Securing the CDL is an important milestone in HYTN’s evolution,” said Jason Broome, Chief Operations Officer of HYTN. “This achievement enhances our capabilities, allowing us to strategically expand beyond GMP-cannabis frameworks and participate directly in pharmaceutical drug development.”

With the CDL in place, HYTN has expanded its capabilities to serve both the regulated cannabis market and the regulated pharmaceutical market, supported by the following strategic advantages:

• Export-Ready GMP-Certified Manufacturing: HYTN operates under a DEL for non-sterile pharmaceuticals and is compliant with international GMP standards recognized by the United Kingdom, European Union and Australia.
• Prescription Drug Development Pathway: With the CDL in place, HYTN can begin developing cannabis-derived drug products. This opens the door to submissions for Marketing Authorisations worldwide.
• EudraGMDP Registration in Progress: HYTN, in conjunction with European partners, is progressing with its EudraGMDP registration, which, if granted, would enable the Company to be listed as an approved active pharmaceutical ingredient (API) and drug product manufacturer within European pharmaceutical databases.
• Contract Development and Manufacturing Organization (CDMO) & Clinical Support: HYTN’s dual licensing enables it to act as a CDMO partner for clinical-stage biotech and pharmaceutical companies, providing GMP-compliant cannabinoid production, formulation development, and product release within a regulated drug framework.

The global pharmaceutical industry is integrating cannabinoids as APIs. Epidiolex, an FDA- and EMA-approved prescription drug derived from cannabidiol (CBD), is authorized for the treatment of severe seizure disorders including Lennox–Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. According to its parent company, Jazz Pharmaceuticals, Epidiolex generated net product sales of USD $972.4 million in 2024, with a reported gross margin of 88.2% of net product sales¹, underscoring the clinical utility and commercial viability of cannabinoid-based pharmaceuticals.

Despite these advancements, access to GMP-compliant, cannabis-derived APIs and finished drug products remains limited, due in part to the high regulatory and operational standards required to serve the pharmaceutical supply chain.

With the recent issuance of its CDL, HYTN joins a small group of global manufacturers equipped to support:

• Clinical-stage pharmaceutical sponsors and biotech companies seeking GMP cannabinoid inputs.
• Distributors and pharmacies in Europe, the UK, and Australia operating under prescription-only frameworks.
• Special access, named patient, and compassionate use programs requiring pharmaceutical-grade supply.
• Government tenders and public health initiatives focused on regulated cannabinoid therapies.

This expanded regulatory scope enables HYTN to participate in the global supply chain for cannabinoid-based therapeutics through internationally compliant manufacturing and strategic pharmaceutical partnerships.

^{1. _{Jazz Pharmaceuticals. Annual Report on Form 10-K/A for the fiscal year ended December 31, 2024.}}

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 and psilocybe-derived tryptamines. 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. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events.

In particular, this press release contains forward-looking information relating to, among other things: the prospect of the Company’s fabrication, packaging, labelling, and distribution of cannabis-containing Rx drugs, including Cannabis-based APIs and finished formulations, and the Company’s ability to produce these products and participate in the supply chain for cannabinoid based therapeutics; and the Company’s EudraGMDP registration, including the anticipated impact on the Company of such registration being granted to the Company. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information, including the assumption that: the Company will be successful in partnering with pharmaceutical sponsors, biotech companies, distributors, pharmacies, governments and/or other participants in the cannabinoid based therapeutics industry, including that these entities will have demand for the Company’s products and that the Company will be able to fulfill the product specifications required by these entities; and that the Company will be granted its EudraGMDP registration on the terms currently anticipated. Those assumptions and factors are based on information currently available to the Company. Although such statements are based on reasonable assumptions of the Company’s management, there can be no assurance that any conclusions or forecasts will prove to be accurate.

Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such factors include: the risk that, even with the CDL, the Company is unsuccessful in partnering with entities in the cannabinoid based therapeutics industry, whether as a result of a lack of demand for the Company’s products, a failure by the Company to manufacture desired products, or otherwise; the risk that the Company is not granted the EudraGMDP license, on the anticipate terms or at all; operational risks; regulatory risks; and financing, capitalization and liquidity risks. The forward-looking information contained in this release is made as of the date hereof, and the Company is not obligated 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. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.

For more information contact:

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.‎

FAQ

What does HYTN's new Cannabis Drug Licence (CDL) allow them to do?

The CDL allows HYTN to manufacture cannabis-derived pharmaceutical drugs, support clinical research, generate regulatory data, and pursue drug approvals and market authorizations in Canada.

How will HYTN's Cannabis Drug Licence impact their business operations?

The licence enables HYTN to expand beyond GMP-cannabis frameworks, develop prescription pharmaceutical products, and serve as a CDMO partner for clinical-stage biotech and pharmaceutical companies.

What is the market potential for cannabis-derived pharmaceuticals based on HYTN's announcement?

The market potential is significant, as demonstrated by Epidiolex, a CBD-derived drug that generated $972.4 million in sales in 2024 with an 88.2% gross margin.

What competitive advantage does HYTN (HYTNF) gain from the Cannabis Drug Licence?

HYTN joins a select group of manufacturers capable of producing GMP-compliant cannabis-derived pharmaceuticals and supporting clinical trials, giving them access to international markets and pharmaceutical partnerships.

What markets can HYTN serve with their new licensing combination?

HYTN can serve clinical-stage pharmaceutical companies, distributors and pharmacies in Europe, UK, and Australia, special access programs, and government initiatives requiring pharmaceutical-grade cannabis products.