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HYTN and SNDL to Collaborate on GMP-Compliant Vape Cartridge Development for Global Markets

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HYTN Innovations has entered into a collaboration agreement with SNDL to develop GMP-compliant vape cartridges for global markets. The partnership, signed on January 17, 2025, leverages HYTN's GMP-certified facility and quality system expertise, while SNDL will provide specialized equipment, cannabis consumables, and capital.

HYTN, holding both a Drug Establishment License and EU GMP equivalent certification under PIC/S, will work on amending licenses, establishing stability programs, and implementing GMP-compliant processes for vape cartridge production. The agreement follows a previous manufacturing partnership and initial purchase order with SNDL announced on January 10, 2025.

The collaboration targets expanding international markets, with UK medical cannabis patients projected to grow 124% from 2024-2028, and the German cannabis vape market expected to reach $966.6 million by 2030. Canada currently supplies approximately 50% of Germany's medical cannabis imports.

HYTN Innovations ha stipulato un accordo di collaborazione con SNDL per sviluppare cartucce per vape conformi alle GMP per i mercati globali. La partnership, firmata il 17 gennaio 2025, sfrutta l'impianto certificato GMP e l'esperienza del sistema di qualità di HYTN, mentre SNDL fornirà attrezzature specializzate, consumabili a base di cannabis e capitale.

HYTN, in possesso di una Licenza di Stabilimento Farmaceutico e di una certificazione equivalente EU GMP sotto PIC/S, lavorerà per modificare le licenze, stabilire programmi di stabilità e implementare processi conformi alle GMP per la produzione di cartucce per vape. L'accordo segue una precedente partnership di produzione e un primo ordine d'acquisto con SNDL annunciato il 10 gennaio 2025.

La collaborazione mira ad espandere i mercati internazionali, con i pazienti di cannabis medica nel Regno Unito che si prevede cresceranno del 124% dal 2024 al 2028, e il mercato delle cartucce di cannabis in Germania che dovrebbe raggiungere i 966,6 milioni di dollari entro il 2030. Attualmente, il Canada fornisce circa il 50% delle importazioni di cannabis medica in Germania.

HYTN Innovations ha entrado en un acuerdo de colaboración con SNDL para desarrollar cartuchos de vapeo que cumplan con las normas GMP para los mercados globales. La asociación, firmada el 17 de enero de 2025, aprovecha las instalaciones certificadas GMP y la experiencia en sistemas de calidad de HYTN, mientras que SNDL proporcionará equipos especializados, consumibles de cannabis y capital.

HYTN, que posee una Licencia de Establecimiento de Medicamentos y certificación equivalente a la EU GMP bajo PIC/S, trabajará en la modificación de licencias, estableciendo programas de estabilidad e implementando procesos conformes a las GMP para la producción de cartuchos de vapeo. El acuerdo sigue a una asociación de fabricación previa y un primer pedido de compra con SNDL anunciado el 10 de enero de 2025.

La colaboración tiene como objetivo expandir los mercados internacionales, con los pacientes de cannabis médico del Reino Unido proyectando un crecimiento del 124% del 2024 al 2028, y se espera que el mercado de vapeo de cannabis en Alemania alcance los $966.6 millones para 2030. Actualmente, Canadá suministra aproximadamente el 50% de las importaciones de cannabis médico de Alemania.

HYTN InnovationsSNDL과 협력 계약을 체결하여 글로벌 시장을 위한 GMP 준수 베이프 카트리지를 개발합니다. 2025년 1월 17일에 서명된 이 파트너십은 HYTN의 GMP 인증 시설 및 품질 시스템 전문성을 활용하며, SNDL은 전문 장비, 대마 소비재 및 자본을 제공합니다.

HYTN은 약물 제조소 라이센스와 PIC/S에 따른 EU GMP 동등 인증을 보유하고 있으며, 라이센스 수정, 안정성 프로그램 설정, 베이프 카트리지 생산을 위한 GMP 준수 프로세스 구현 작업을 진행합니다. 이 계약은 2025년 1월 10일 발표된 SNDL과의 이전 제조 파트너십 및 초기 구매 주문에 이어집니다.

이번 협력은 국제 시장 확장을 목표로 하며, 2024년부터 2028년까지 영국의 의료 대마 환자가 124% 성장할 것으로 예상되고, 독일의 대마 베이프 시장은 2030년까지 9억 6,660만 달러에 이를 것으로 예상됩니다. 현재 캐나다는 독일의 의료 대마 수입의 약 50%를 공급하고 있습니다.

HYTN Innovations a conclu un accord de collaboration avec SNDL pour développer des cartouches de vape conformes aux GMP pour les marchés mondiaux. Le partenariat, signé le 17 janvier 2025, tire parti des installations certifiées GMP et de l'expertise du système de qualité de HYTN, tandis que SNDL fournira des équipements spécialisés, des consommables à base de cannabis et du capital.

HYTN, qui détient une licence d'établissement pharmaceutique et une certification équivalente à l'UE GMP selon le PIC/S, travaillera à la modification des licences, à l'établissement de programmes de stabilité et à la mise en œuvre de processus conformes aux GMP pour la production de cartouches de vape. L'accord fait suite à un précédent partenariat de fabrication et à une première commande passée auprès de SNDL annoncée le 10 janvier 2025.

La collaboration vise à étendre les marchés internationaux, avec une croissance projetée de 124 % des patients de cannabis médical au Royaume-Uni entre 2024 et 2028, et le marché allemand du vape de cannabis devrait atteindre 966,6 millions de dollars d'ici 2030. Le Canada fournit actuellement environ 50 % des importations de cannabis médical en Allemagne.

HYTN Innovations hat einen Kooperationsvertrag mit SNDL abgeschlossen, um GMP-konforme Vape-Kartuschen für globale Märkte zu entwickeln. Die Partnerschaft, die am 17. Januar 2025 unterzeichnet wurde, nutzt die GMP-zertifizierte Einrichtung und das Fachwissen von HYTN im Qualitätsmanagement, während SNDL spezialisierte Geräte, Cannabisprodukte und Kapital bereitstellt.

HYTN, das sowohl eine Arzneimittelhersteller-Lizenz als auch eine EU GMP-äquivalente Zertifizierung nach PIC/S besitzt, wird daran arbeiten, Lizenzen zu ändern, Stabilitätsprogramme einzurichten und GMP-konforme Prozesse für die Produktion von Vape-Kartuschen umzusetzen. Die Vereinbarung folgt einer vorherigen Herstellpartnerschaft und einer ersten Bestellung bei SNDL, die am 10. Januar 2025 angekündigt wurde.

Die Zusammenarbeit zielt darauf ab, internationale Märkte zu erweitern, wobei die Zahl der Patienten mit medizinischem Cannabis im Vereinigten Königreich von 2024 bis 2028 voraussichtlich um 124 % steigen wird, und der deutsche Cannabis-Vape-Markt bis 2030 voraussichtlich 966,6 Millionen US-Dollar erreichen wird. Kanada beliefert derzeit etwa 50 % der medizinischen Cannabisimporte Deutschlands.

Positive
  • Partnership with major cannabis company SNDL provides equipment and capital support
  • Access to growing international markets with significant revenue potential
  • Company holds strategic EU GMP certification and Drug Establishment License
Negative
  • No volume commitments or pricing terms established in the agreement
  • Non-exclusive partnership allows competition from other manufacturers

VANCOUVER, British Columbia, Jan. 21, 2025 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) (“HYTN” or the “Company”), a company specializing in pharmaceutical-grade cannabis manufacturing, is pleased to announce that it has entered into a collaboration agreement (the Agreement) with SNDL Inc. (NASDAQ: SNDL) ("SNDL"), one of the world’s largest vertically integrated cannabis companies, to jointly develop Good Manufacturing Practices (GMP) compliant vape cartridges.

Leveraging HYTN’s GMP-certified facility and expertise in quality system development, SNDL will provide specialized equipment, cannabis consumables, and the required capital to meet stringent regulatory requirements for GMP product development. HYTN will endeavour to amend its licenses and/or certificates, establish a stability program, and implement GMP-compliant processes tailored for vape cartridge production. This initiative follows the Company’s January 10, 2025, announcement of a manufacturing partnership and initial purchase order with SNDL.

“HYTN holds both a Drug Establishment License and EU GMP equivalent certification under the International Pharmaceutical Cooperation Scheme (PIC/S), making it one of the few facilities in Canada capable of manufacturing vape cartridges for international distribution,” stated Jason Broome, HYTN’s Chief Operations Officer. “This collaboration with SNDL is expected to provide the resources required to rapidly amend our manufacturing systems and deliver vape cartridges to pharmaceutical markets.”

Under the Agreement which was signed January 17, 2025, neither HYTN nor SNDL are obligated to exclusivity. While key milestones include the processing of three (3) commercial batches, there is no obligation regarding sales volume or pricing terms. Upon completion of the development phase, both parties may explore a commercial manufacturing agreement for vape cartridges.

The market for GMP-compliant cannabis vape products continues to expand. The number of medical cannabis patients in the UK is projected to increase by 124% from 2024 - 2028¹, and the German cannabis vape market is expected to reach 966.6 million USD by 2030², with Canada accounting for approximately 50% of Germany’s medical and scientific cannabis imports. These trends underscore HYTN’s strategic focus on GMP manufacturing to meet evolving international requirements.

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 SNDL Inc.

SNDL is a public company whose shares are traded on the Nasdaq under the symbol "SNDL." SNDL is the largest private-sector liquor and cannabis retailer in Canada with retail banners that include Ace Liquor, Wine and Beyond, Liquor Depot, Value Buds, Spiritleaf, and Superette. SNDL is a licensed cannabis producer and one of the largest vertically integrated cannabis companies in Canada specializing in low-cost biomass sourcing, indoor cultivation, product innovation, low-cost manufacturing facilities, and a cannabis brand portfolio that includes Pearls by Grön, No Future, Bhang Chocolate, Top Leaf, Contraband, Citizen Stash, Sundial Cannabis, Palmetto, Spiritleaf Selects, Bon Jak, Versus, Value Buds, Namaste, Re-up, Grasslands and Vacay. SNDL's investment portfolio seeks to deploy strategic capital through direct and indirect investments and partnerships throughout the North American cannabis industry. For more information on SNDL, please go to https://sndl.com/.

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.

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

1. Prohibition Partners. (2024). UK's medical cannabis boom: Patients, demand, and consumption surge to all-time highs – With a record number of private clinics. Article.

2. Lamers, M. (2024). German cannabis imports rise to 34.6 tons as cultivators eye the end of the quota system. Article.

Forward Looking Information Disclaimer

This news release contains statements and information that constitute “forward-looking information” within the meaning of applicable securities laws. Such information is based on current expectations, estimates, forecasts, projections, beliefs and assumptions made by management of the Company. Forward-looking information may include financial and other projections, as well as statements regarding future plans, strategies, prospects, objectives or economic performance, or the assumption underlying any of the foregoing. In some cases, forward-looking statements can be identified by terms such as “may”, “would”, “could”, “will”, “likely”, “except”, “potential”, “anticipate”, “believe”, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook”, or the negative thereof or other similar expressions concerning matters that are not historical facts. Examples of such statements within this news release include but are not limited to the expectation that SNDL will provide the Company with the resources required to manufacture and market vape cartridges;  the anticipated demand for vape cartridges; and the ability of the Company to produce vape cartridges and obtain any or all required regulatory approvals.

Forward-looking information is based on current expectations, assumptions, estimates, forecasts, projections, analysis and opinions of management made considering its experience and its perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances at the date that such statements are made, but which may prove to be incorrect. The material factors and assumptions used to develop the forward-looking information contained in this news release include, but are not limited to: regulatory requirements being obtained and maintained; ‎general business, economic and political conditions; the Company’s ability to successfully execute its plans ‎and intentions; the availability of financing on reasonable terms; the Company’s ability ‎to attract and retain skilled staff; market competition; the products and technology offered by competitors; and that good relationships with service providers and other third parties will be ‎established and maintained.

Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, including, without limitation the Company’s limited operating history; negative cash flow; financial position and results of operations differing materially from expectations; the expectation of incurring future losses and never becoming profitable; requiring additional capital to continue operations; reliance on the third-party service providers; strong competition from competitors; regulatory changes that may adversely affect the Company;‎ and other risk factors described in the Company’s regulatory filings. Accordingly, readers should not place undue reliance on any such forward-looking information. Further, any forward-looking information speaks only as of the date on which such statement is made. New factors emerge from time to time, and it is not possible for the Company’s management to predict all such factors and to assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking information. The Company does not undertake any obligation to update any forward-looking information to reflect information or events after the date on which it is made or to reflect the occurrence of unanticipated events, except as required by law, including securities laws.

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.


FAQ

What is the value of the German cannabis vape market potential for HYTNF by 2030?

The German cannabis vape market is expected to reach 966.6 million USD by 2030, presenting a significant opportunity for HYTNF as Canada currently supplies about 50% of Germany's medical cannabis imports.

What certifications does HYTNF hold for international vape cartridge manufacturing?

HYTN holds both a Drug Establishment License and EU GMP equivalent certification under the International Pharmaceutical Cooperation Scheme (PIC/S), making it one of few Canadian facilities capable of international vape cartridge manufacturing.

What are the key terms of HYTNF's collaboration agreement with SNDL signed on January 17, 2025?

The agreement includes SNDL providing equipment, cannabis consumables, and capital, while HYTN will develop GMP-compliant processes. The partnership is non-exclusive and requires processing of three commercial batches, but has no volume or pricing commitments.

What is the projected growth rate of UK medical cannabis patients for HYTNF's target market?

The number of medical cannabis patients in the UK is projected to increase by 124% from 2024 to 2028, representing a significant growth opportunity for HYTNF's GMP-compliant products.

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