VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a Canadian-based company licensed by Health Canada to produce natural, scalable, and accessible psychedelic and functional mushrooms for transformational human experiences, has received permission from Health Canada to manufacture and distribute additional psychedelic substances, most notably MDMA, under the amended terms outlined in its June 20, 2022 application to Health Canada.

Under the leadership of Chief Science Officer Justin Kirkland, Optimi will now act as wholesale supplier of MDMA and other synthetic psychedelic compounds to approved researchers and drug developers.

The Company is scheduled to begin production and analytical testing of MDMA this October in its recently completed EU-GMP pharmaceutical manufacturing facility.

Optimi CEO, Bill Ciprick, says the Company’s in-house capacity to produce a wide range of scalable formulations puts Optimi at the forefront of the commercial manufacturing and supply of psychedelics.

“From lab to market, Optimi has taken every step necessary to build its competitive position as a global leader in the manufacturing of EU-GMP compliant MDMA in North America, and we’ve done that through operational transparency and investing in smart infrastructure.”

He further added, “On compliance, quality, and scale, we have consistently demonstrated our plan to lead the industry in API synthesis and formulation, which gives our science and operations team the confidence to develop saleable psychedelic products that are supported by rigorous in-house Standard Operating Procedures (SOP),” said Ciprick.

The terms of the amendment took effect as of Friday, August 5, 2022, and will allow the Company to increase the overall output potential of its Princeton, British Columbia facility to better address the needs of the evolving psychedelic market as part of Optimi’s planned year of commercialization.

Since applying for the amendment in June, the Company has met with industry stakeholders, drug developers, and clinical trial researchers interested in exploring Optimi’s production capabilities, reaffirming the Company’s decision to proceed with this phase of its commercialization strategy.
Regulatory Opportunity

In May 2022 it was reported by online publication, The Intercept, that the Joe Biden administration was anticipating FDA regulation of MDMA and psilocybin within the next two years and was “exploring the prospect of establishing a federal task force” to review the psychedelic ecosystem.

With 130 MDMA clinical trials currently listed between Canada and United States, and the prospect of the Biden Administration looking to regulate MDMA and psilocybin, Optimi is already preparing for future international and domestic regulatory movement that could positively impact the Company.

“The regulatory landscape in the U.S and Canada is always evolving, specifically with the Canadian government’s recent decision to decriminalize MDMA up to 2.5 grams in British Columbia,” said Optimi regulatory affairs advisor, Michael Kydd. “Governments often use incremental shifts in policy to test public sentiment, which sometimes triggers broader policy change down the road. Having a licence to produce EU-GMP MDMA at an unmatched scale will benefit the Company when we eventually see these wholesale policy changes,” added Kydd.

On August 10, Optimi unveiled Blue Serenity Natural Psilocybin in collaboration with renowned psilocybin advocate, Thomas Hartle. The product is now available to patients who face a serious or life-threatening condition and have been approved under Canada’s Special Access Program.

In addition to MDMA, the Company now has Health Canada approval to manufacture and distribute additional substances including:

N,N-Dimethyltryptamine (“DMT”);

3,4,5-trimethoxyphenethylamine (“Mescaline”);

2-(2-chlorophenyl)-2- (methylamino)cyclohexanone (“Ketamine”);

Lysergic Acid Diethylamide (“LSD”);

1-(1-phenylcyclohexyl)piperidine (“Phencyclidine”);

4-Hydroxybutanoic Acid (“GHB”);

4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole (“Harmaline”);

4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol (“Harmalol”);

Salvia Divinorum, Salvinorin A; and,

4-Bromo-2,5-Dimethoxybenzeneethanamine (“2C-B”).

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other additional psychedelics are invited to contact [email protected] where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi’s products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.

Company to maximize world-class EU-GMP operations, potentially opening future revenue- generating opportunities 

June 20, 2022

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi”) or the (“Company”), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, has submitted a request with Health Canada for an amendment to its Controlled Substances Dealer’s Licence.

The amendment would enable the Company to synthesize, process and distribute pharmaceutical grade 3,4-Methylenedioxymethamphetamine (“MDMA”), among other substances, at its Princeton, British Columbia facility.

With the Company’s main capital expenditure now completed, it will move to expand its offering to encompass a wide variety of synthetic psychedelics through its market-leading EU-GMP cultivation and analytical laboratory. The move aligns with Optimi’s planned year of commercialization, allowing the Company to maximize revenue-generating opportunities through standardized psychedelic drug testing, R&D, and product development through approved clinical trials and exemption-based applications.

Ongoing large-scale studies, including Phase III clinical trials investigating MDMA conducted by the Multidisciplinary Association for Psychedelic Studies (“MAPS”), along with more recent decriminalization initiatives announced in the Province of British Columbia, have generated significant unmet demand for these substances for research purposes.

Optimi Health Chief Science Officer Justin Kirkland stated that, “Since our inception, Optimi has received a steadily increasing volume of inquiries related to the production of synthetic psychedelics from stakeholders within the sector, made all the more timely by recent developments. Our analytical laboratories were purpose-built to enable us to act as an EU-GMP compliant drug manufacturer for these interests, without in any way detracting from our primary goal of cultivating natural psilocybin.”

Mr. Kirkland elevates Optimi as an industry leader utilizing his drug manufacturing expertise shown in his USPTO awarded Bromo-LSD manufacturing patent sold in 2020 for C$10M and GMP regulatory knowledge from his role as CEO at FDA registered Fristoe Pharmaceuticals.

Optimi CEO, Bill Ciprick, says the Company’s EU-GMP operational footprint and throughput capacity is unmatched in North America and would likely take new entrants into the space years and millions of dollars to meet Optimi’s scale and clinical efficiency.

“We have a strong idea of our position in the market and how the amendment fits with our strategic priorities,” said Ciprick. “We are filing this amendment following conversations with researchers and drug developers which have led to a high volume of requests for GMP-compliant synthetic psychedelics. The positive reports from trauma sufferers, including veterans groups, for whom substances such as MDMA might make a difference, mean that safe, scalable supply is going to be more crucial than ever to the success of psychedelic medicine.”

“As we continue with our planned year of commercialization, Optimi views the capacity to produce and distribute these substances as integral to our overall positioning and revenue generation within the sector’s supply chain,” Ciprick concluded.

The Company’s amendment application to Health Canada also includes:

N,N-Dimethyltryptamine (“DMT”);
3,4,5-trimethoxyphenethylamine (“Mescaline”);
2-(2-chlorophenyl)-2- (methylamino)cyclohexanone (“Ketamine”);
Lysergic Acid Diethylamide (“LSD”);
1-(1-phenylcyclohexyl)piperidine (“Phencyclidine”);
4-Hydroxybutanoic Acid (“GHB”);
4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole (“Harmaline”);
4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol (“Harmalol”);
Salvia Divinorum, Salvinorin A; and,
4-Bromo-2,5-Dimethoxybenzeneethanamine (“2C-B”).

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations
Email: [email protected]
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca