HYTN Drug Establishment Licence Expanded to Include Active Pharmaceutical Ingredients and Pharmaceutical Oils

VANCOUVER, British Columbia, May 07, 2026 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC Pink: HYTNF) (“HYTN” or the “Company”), a pharmaceutical manufacturer specializing in products containing psychoactive and psychotropic compounds, is pleased to announce that its Health Canada Drug Establishment Licence (DEL) has been amended following a comprehensive Good Manufacturing Practices (GMP) inspection of its Kelowna, British Columbia Facility.

Under the amended licence, issued by Health Canada, HYTN is now authorized to fabricate, package, and label non-sterile Active Pharmaceutical Ingredients (API) in both solid and non-solid forms, and adds Pharmaceutical Oil as an authorized finished dosage form. The updated scope of the license expands the Company's GMP manufacturing activities and supports its ability to service both pharmaceutical and cannabinoid supply chains subject to applicable product-specific, customer-specific, import, release, and jurisdictional requirements.

The Company notes that the amended licence, together with its previously announced Cannabis Drug Licence, Cannabis Processing Licence, and expanded DEL dosage form authorizations, permits additional regulated manufacturing activities at HYTN’s Kelowna facility. These activities may support HYTN’s participation in regulated drug-development and pharmaceutical manufacturing programs involving cannabinoid-derived inputs and finished dosage forms, where applicable product-specific, customer-specific, import, release, drug control, and jurisdictional requirements are satisfied. The amendment represents a progression from manufacturing cannabis products to GMP specifications toward additional pharmaceutical manufacturing activities authorized under the DEL.

The Company further notes that Canada has been added to the European Commission’s list of third countries whose regulatory framework for active substances has been assessed as equivalent for purposes of EU active substance importation. As a result, certain EU written confirmation requirements applicable to active substances imported from non-listed countries may be waived for Canadian-manufactured APIs, subject in all cases to applicable EU, importer, product-specific, and jurisdictional requirements. This does not constitute automatic EU market access, product approval, or authorization to import any specific product in the European Union.

"This licence amendment represents an important operational milestone for HYTN and demonstrates the continued development of our GMP manufacturing capabilites" said Jason Broome, Chief Operating Officer of HYTN. "Being permitted to fabricate both solid and non-solid API, as well as pharmaceutical oil dosage forms under our DEL expands the regulated manufacturing capabilities at our Kelowna facility and further demonstrates the capabilities that support current and future pharmaceutical manufacturing programs."

The Company believes the amended DEL will provide greater flexibility to support its regulated activities in domestic and international markets, including the manufacture of cannabinoid-based APIs and finished dosage forms where permitted. HYTN continues to supply products into federally regulated medical and pharmaceutical markets in Germany, the United Kingdom, and Australia, while evaluating opportunities that align with its GMP manufacturing platform, licence portfolio, and quality systems. The amended DEL does not itself announce or imply any new contract, customer, purchase order, product approval, revenue, or market authorization. Export, import, sale, release, or use of any product remains subject to applicable customer, importer, product-specific, drug control, quality, and jurisdictional requirements.

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. The Company serves federally regulated markets worldwide by applying pharmaceutical-grade development, manufacturing, and quality systems.

For More Information Contact
Elliot McKerr
Chief Executive Officer
HYTN Innovations Inc.

HYTN Investor Relations
1.866.590.9289
investments@hytn.life

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

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 using words such as “intend,” “expect,” “may,” “will,” “anticipate,” “believe,” and similar expressions, or by 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 anticipated benefits and commercial impact of the amended Drug Establishment Licence; the Company's capabilities to successfully fabricate, package, label, and distribute non-sterile Active Pharmaceutical Ingredients (API) in solid and non-solid forms, as well as pharmaceutical oils; the Company’s ability to scale the production of premium cannabis-based pharmaceuticals; the Company’s strategy and ongoing ability to supply international and domestic pharmaceutical markets, including the United Kingdom and Germany; and the Company's ability to maintain Good Manufacturing Practices (GMP) and satisfy evolving regulatory requirements.

Forward-looking information is based on certain assumptions, including, but not limited to: the assumption that the Company will maintain the licences, infrastructure, personnel, and operational capacity necessary to manufacture APIs and finished dosage forms; that domestic and international customer demand for the Company's products will develop or continue; that applicable regulatory, quality, import, and customer-specific requirements in target global markets will be satisfied; and that the Company will have sufficient resources to pursue related commercial and export opportunities. 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, events, or outcomes to differ materially from those expressed or implied by such forward-looking information. These risks and uncertainties include, without limitation: regulatory risks in Canada and international markets, including potential changes to DEL or GMP requirements; the risk that international or domestic commercial demand for cannabis-based APIs or oil dosage forms may not develop as anticipated; the risk that potential counterparties may not proceed with purchase agreements; the risk that customer, importer, or jurisdiction-specific requirements may differ from the Company’s expectations; operational risks associated with scaling new manufacturing capabilities; supply chain disruptions; and financing 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 because 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.

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