HYTN Expands GMP Capabilities with New Licensed Activity

HYTN receives certification for GMP distribution to international markets


VANCOUVER, British Columbia, Oct. 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) (“HYTN” or “the Company”), a pharmaceutical company specializing in the development, formulation, and manufacturing of psychoactive and psychotropic compounds, including cannabis and psilocybin, proudly announces that it has received an additional Good Manufacturing Practices (“GMP”) certification for its Kelowna manufacturing facility. This certification now includes distribution as a licenced activity under HYTN's Drug Establishment Licence (“DEL”) issued by Health Canada.

This new activity builds on HYTN's existing GMP certification, which was issued under the International Pharmaceutical Co-operation Scheme (“PIC/S”) and by Heath Canada. HYTN is already authorized to fabricate, package, and label non-sterile pharmaceutical products. The addition of distribution allows the company to distribute GMP-certified products directly, though HYTN may still collaborate with regional distributors as needed depending on market demands.

“We have once again demonstrated the compliance of our facility and quality systems,” said Jason Broome, HYTN's Chief Operations Officer. “This licence amendment further supports our expansion into non-sterile pharmaceutical production and enables us to distribute our products in markets where this is required.”

GMP certification is critical for the sale of non-sterile pharmaceuticals, including cannabis medicines, in markets such as Germany, the United Kingdom, Australia, and Poland.

The company also announces that it has granted 200,000 Restricted Share Units (“RSU”) to certain consultants of the Company pursuant to the Company’s Equity Incentive Plan.

About HYTN Innovations Inc.

HYTN Innovations Inc. is a pharmaceutical company that specializes 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 Good Manufacturing Practices (GMP)

Good manufacturing practice 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.

About Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a global initiative aimed at standardizing Good Manufacturing Practices (GMP) across its 56 member countries, thereby facilitating international trade in pharmaceuticals. Established to ensure the quality and safety of medicines for human and veterinary use, PIC/S promotes harmonized GMP standards and mutual recognition of inspection results among regulatory authorities, streamlining the approval process for pharmaceutical manufacturers

For more information contact:

Elliot McKerr
Chief Executive Officer
1.866.590.9289

HYTN Investor Relations:

1.866.590.9289
investments@hytn.life

Forward-Looking Statements

Certain information contained herein may constitute forward-looking statements that involve risks and uncertainties. Readers are cautioned not to place undue reliance on forward-looking statements, including, but not limited to, statements regarding: (i) The potential for the partnership to expand through additional products or services, facilitated by this licence amendment. (ii) The anticipated growth in market share across the UK, Germany, and Australia, driven by this licence amendment. (iii) The expected benefits of leveraging GMP certifications to access and penetrate new international markets. Factors that could cause actual results to vary from forward-looking statements or may affect the operations, performance, development, and results of the Company’s business include, among other things: the Company's failure to generate sufficient cash flow from operations to meet its current and future obligations; the Company's failure to access sources of debt and equity capital; changes to the regulatory framework within which the Company operates; competitive factors, pricing pressures, and supply and demand in the Company’s industry; and general economic and business conditions. Any statements that are not statements of historical fact are deemed to be forward-looking statements. The forward-looking statements contained in this news release are made as of the date of this news release, and, except to the extent required by applicable law, the Company assumes no obligation to update or revise forward-looking statements made herein or otherwise, whether because of new information, future events, or otherwise. The forward-looking statements contained in this news release are expressly qualified by this cautionary note.

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