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HYTN Partners with the UK's 4C Labs, Validates GMP Certification

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HYTN Innovations Inc. (CSE: HYTN, OTC PINK: HYTNF) has announced international manufacturing and pricing agreements with 4C LABS, a leading UK cannabis-based pharmaceuticals distributor. This partnership enables HYTN to produce bulk and final packaged cannabis products for distribution in the UK and other global markets. HYTN's GMP license from Health Canada and PIC/S certification from Australia's TGA are important for this collaboration.

The partnership aims to enhance operational efficiency by manufacturing new products and co-manufacturing existing ones. HYTN's CEO, Elliot McKerr, emphasized that this collaboration validates their regulatory work and positions them for international market expansion. The partnership also targets growth opportunities in Germany and Australia, with their respective medical cannabis markets valued at CAD $2 billion and AUD $200 million in 2022.

HYTN Innovations Inc. (CSE: HYTN, OTC PINK: HYTNF) ha annunciato accordi internazionali per la produzione e la definizione dei prezzi con 4C LABS, un importante distributore di prodotti farmaceutici a base di cannabis nel Regno Unito. Questa partnership consente a HYTN di produrre prodotti a base di cannabis in quantità e confezionati per la distribuzione nel Regno Unito e in altri mercati globali. La licenza GMP di HYTN da Health Canada e la certificazione PIC/S dalla TGA australiana sono fattori cruciali per questa collaborazione.

La partnership mira a migliorare l'efficienza operativa attraverso la produzione di nuovi prodotti e la co-manifattura di quelli esistenti. Il CEO di HYTN, Elliot McKerr, ha sottolineato che questa collaborazione convalida il loro lavoro normativo e li prepara per un espansione nei mercati internazionali. La partnership si prefigge anche di sfruttare opportunità di crescita in Germania e Australia, con i rispettivi mercati della cannabis medica valutati a CAD $2 miliardi e AUD $200 milioni nel 2022.

HYTN Innovations Inc. (CSE: HYTN, OTC PINK: HYTNF) ha anunciado acuerdos internacionales de fabricación y precios con 4C LABS, un destacado distribuidor de productos farmacéuticos a base de cannabis en el Reino Unido. Esta asociación permite a HYTN producir productos de cannabis a granel y envasados para su distribución en el Reino Unido y otros mercados globales. La licencia GMP de HYTN de Health Canada y la certificación PIC/S de la TGA australiana son importantes para esta colaboración.

El objetivo de la asociación es mejorar la eficiencia operativa mediante la fabricación de nuevos productos y la co-manufactura de los existentes. El CEO de HYTN, Elliot McKerr, enfatizó que esta colaboración valida su trabajo regulatorio y los posiciona para una expansión en mercados internacionales. La asociación también apunta a las oportunidades de crecimiento en Alemania y Australia, con mercados de cannabis medicinal valorados en CAD $2 mil millones y AUD $200 millones en 2022.

HYTN Innovations Inc. (CSE: HYTN, OTC PINK: HYTNF)는 영국의 선두 마리화나 기반 제약 유통업체인 4C LABS와 국제 제조 및 가격 계약을 발표했습니다. 이 파트너십을 통해 HYTN은 영국 및 기타 글로벌 시장에서 유통할 대량 및 최종 포장된 대마초 제품을 생산할 수 있습니다. HYTN의 GMP 라이센스는 Health Canada에서, 그리고 호주 TGA의 PIC/S 인증은 이 협력에 중요합니다.

파트너십은 새로운 제품을 제조하고 기존 제품을 공동 생산하여 운영 효율성을 높이는 것을 목표로 합니다. HYTN의 CEO인 엘리엇 맥커는 이 협력 관계가 그들의 규제 작업을 검증하고 국제 시장 확장을 위한 입지를 다진다고 강조했습니다. 이 파트너십은 또한 독일과 호주의 성장 기회에 집중하며, 각국의 의료용 대마초 시장은 2022년 기준으로 CAD $20억 및 AUD $2억에 달합니다.

HYTN Innovations Inc. (CSE: HYTN, OTC PINK: HYTNF) a annoncé des accords internationaux de fabrication et de tarification avec 4C LABS, un distributeur de produits pharmaceutiques à base de cannabis basé au Royaume-Uni. Ce partenariat permet à HYTN de produire des produits à base de cannabis en vrac et emballés pour distribution au Royaume-Uni et sur d'autres marchés mondiaux. La licence GMP d'HYTN délivrée par Health Canada et la certification PIC/S de l'Australian TGA sont essentielles pour cette collaboration.

Le partenariat vise à améliorer l'efficacité opérationnelle en fabriquant de nouveaux produits et en co-manufacturant des produits existants. Le PDG d'HYTN, Elliot McKerr, a souligné que cette collaboration valide leur travail réglementaire et les prépare à une expansion sur les marchés internationaux. Le partenariat vise également à saisir des opportunités de croissance en Allemagne et en Australie, avec des marchés de cannabis médicinal évalués respectivement à CAD $2 milliards et AUD $200 millions en 2022.

HYTN Innovations Inc. (CSE: HYTN, OTC PINK: HYTNF) hat internationale Fertigungs- und Preisvereinbarungen mit 4C LABS, einem führenden britischen Distributor von cannabinoidbasierten Arzneimitteln, bekannt gegeben. Diese Partnerschaft ermöglicht es HYTN, großzügig produzierte und verpackte Cannabisprodukte für die Verteilung im Vereinigten Königreich und anderen globalen Märkten herzustellen. Die GMP-Lizenz von HYTN, die von Health Canada erteilt wurde, sowie die PIC/S-Zertifizierung von Australiens TGA sind für diese Zusammenarbeit von großer Bedeutung.

Die Partnerschaft zielt darauf ab, die operative Effizienz zu steigern, indem neue Produkte hergestellt und bestehende gemeinsam gefertigt werden. Der CEO von HYTN, Elliot McKerr, betonte, dass diese Zusammenarbeit ihre regulatorische Arbeit bestätigt und sie für eine internationale Marktexpansion positioniert. Diese Partnerschaft zielt auch auf Wachstumsmöglichkeiten in Deutschland und Australien ab, wobei die jeweiligen Märkte für medizinisches Cannabis im Jahr 2022 auf CAD $2 Milliarden und AUD $200 Millionen geschätzt werden.

Positive
  • Partnership with 4C LABS enables HYTN to enter the UK cannabis market
  • HYTN's GMP license and PIC/S certification facilitate international partnerships
  • Opportunity for operational efficiency through co-manufacturing
  • Potential expansion into German and Australian markets
  • Validation of HYTN's regulatory work and manufacturing processes
Negative
  • No fixed, mandatory, or minimum order commitment from 4C LABS

VANCOUVER, British Columbia, Sept. 10, 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 cannabinoids and psilocybin, is proud to announce the establishment of international manufacturing and pricing agreements (the Agreements) with 4C LABS, a leading importer and distributor of cannabis-based pharmaceuticals in the United Kingdom. These agreements aim to enable the production of cannabis products in bulk and final packaged forms for distribution in the UK and other global markets. Through this partnership HYTN will act as the manufacturer, packager and exporter of pharmaceutical quality cannabis goods that 4C LABS may purchase and subsequently import and distribute into the UK market.  

HYTN's Good Manufacturing Practice (GMP) license, granted by Health Canada, and its PIC/S certification from Australia's Therapeutic Goods Administration (TGA), are key credentials that enable partnerships with internationally accredited distributors, these credentials, combined with 4C LABS’ expertise and licences in cannabis operations in the UK, create a robust foundation for the business collaboration with 4C Labs. Under the Agreements, HYTN intends to manufacture new products for 4C LABS while also serving as a co-manufacturing center for the production of existing products currently produced at various locations, with the aim of enhancing operational efficiency for both companies. The agreements do not provide for a fixed, mandatory or minimum order by 4C LABS.

“This partnership validates the ongoing regulatory work HYTN has been undertaking,” stated Elliot McKerr, Chief Executive Officer of HYTN. Adding “By integrating 4C Labs’ deep understanding of cannabis procurement and consumer demand with our advanced GMP-certified manufacturing processes, we are well-positioned to deliver high quality cannabis products to international markets. This collaboration not only highlights our commitment to expanding the company's global presence but also marks a significant milestone in HYTN's advancement into non-sterile pharmaceutical production.”

Greg Dobbin, Chief Executive Officer of 4C LABS, added, “Partnering with HYTN provides us with a significant competitive advantage. HYTN’s proximity to high quality Canadian cannabis flower, coupled with their rigorous adherence to GMP standards and innovative manufacturing platform, will allow us to work towards delivering top quality products and competitive pricing to our customers.”

While the initial focus of this partnership is to supply products to the UK market, both companies recognize substantial growth opportunities in Germany and Australia. The German medical cannabis market is rapidly emerging as one of Europe’s largest, with an estimated value of CAD $2 billion1, while the Australian market, valued at over AUD $200 million in 20222, continues to expand. As these markets require GMP-certified production and distribution, both firms have identified this partnership as providing the necessary framework to support global expansion.

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 4C LABS Ltd.

4C LABS is a Canadian based Medical Cannabis company which is building a vertically integrated, quality-driven infrastructure for procuring and delivering premium medical cannabis products to the UK, EU and other international regulated markets.

4C LABS focuses on launching products in regulated markets with an additional focus on research and development of new and innovative plant based therapeutic finished product forms that can be introduced to the 4C catalogue.

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

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

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 expansion of the partnership to include additional products or services; (ii) the expected growth in market share within the UK, Germany, and Australia as a result of this partnership; (iii) the anticipated benefits from leveraging GMP certifications in penetrating new international markets; and (iv) the potential to generate sales and manufacturing activity from the partnership with 4C Labs. 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.

J Green. International Cannabis Business Conference (July 8, 2024) - Germany’s Medical Cannabis Industry Is Booming

J. Ryan, Pennington Institute (December 2023), Cannabis in Australia


FAQ

What is the significance of HYTN's partnership with 4C LABS for HYTNF stock?

The partnership allows HYTN to enter the UK cannabis market, potentially increasing revenue and market presence. It also validates HYTN's GMP certification and manufacturing capabilities, which could positively impact HYTNF stock.

How does HYTN's GMP certification benefit its international expansion plans?

HYTN's GMP license from Health Canada and PIC/S certification from Australia's TGA enable partnerships with internationally accredited distributors, facilitating entry into global markets like the UK, Germany, and Australia.

What are the potential market opportunities for HYTN (HYTNF) in Germany and Australia?

The German medical cannabis market is estimated at CAD $2 billion, while the Australian market was valued at over AUD $200 million in 2022. Both markets require GMP-certified production, aligning with HYTN's capabilities.

Does the agreement with 4C LABS guarantee a minimum order volume for HYTN (HYTNF)?

No, the agreements do not provide for a fixed, mandatory, or minimum order by 4C LABS, which could be seen as a potential risk for HYTN's revenue projections.

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