Optimi Health Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

Optimi Health Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

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: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company's dealer's license and associated business related to Psilocybin and Psilocin and Optimi's plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bb41a009-e2a5-4d5d-bf10-082d7a8dfeb1


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

OPTI:CC
The Conversation (0)
Optimi Health Announces Closing of Strategic Non-Brokered Private Placement

Optimi Health Announces Closing of Strategic Non-Brokered Private Placement

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF U.S. SECURITIES LAWS.

Highlights:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Alberta Puts Patients First By Regulating Psychedelic Therapy: Optimi Health

Alberta Puts Patients First By Regulating Psychedelic Therapy: Optimi Health

Highlights:

  • The safe supply of psychedelic drug products manufactured at a GMP-level is critical in treating serious mental health issues. Minister of Mental Health and Addictions, the Honourable Carolyn Bennett, has publicly stated that safe drug supply is paramount to reducing overdose deaths.
  • Optimi Health is the largest cultivator of natural EU-GMP psilocybin and MDMA in North America.
  • Optimi Health is licensed by Health Canada to supply clinical trials and patients approved under the Special Access Program.

Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a leading Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is applauding the government of Alberta's decision to regulate some psychedelics for therapeutic use in the province.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada

Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada

Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is pleased to announce that in conjunction with ATMA Journey Centers ("ATMA"), the companies have confirmed their intent to proceed with a Phase I clinical trial application (CTA) that will document the safety of the Optimi's natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients.

Upon Health Canada approval, it would be the first trial to assess both safety and additional markers, such as the mystical experience questionnaire in healthy subjects that have consumed MDMA.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Optimi Health Completes Largest Legal Natural Psilocybin Harvest in Canadian History

Optimi Health Completes Largest Legal Natural Psilocybin Harvest in Canadian History

Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), is pleased to announce that it has completed what it believes to be the largest legal natural psilocybin harvest in Canadian history. The Company is licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, as well as functional mushrooms that focus on the health and wellness markets.

Building off its first official harvest on May 27 th , which produced various strains of psilocybin for lab analysis and early-stage supply agreements, the Company is pleased to report that its investment in state-of-the art environmental controls and facility cultivation operations have resulted in a commercially harvested yield of more than 150 kg of Panaeolus cyanescens and Psilocybe cubensis.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Optimi Health Signs First International Mushroom Supply Agreement with UK-based Avida Global

Optimi Health Signs First International Mushroom Supply Agreement with UK-based Avida Global

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 mushroom products for transformational human experiences, is pleased to announce that it has entered into an agreement with Avida Global ("Avida"), a privately-held UK-based producer of high-quality wellness products, including nutraceuticals and medicinal cannabis oils, for the global well-being and medical markets.

In its first large-scale international distribution agreement, Optimi will supply Avida with an extensive catalog of Optimi Life functional mushroom supplement formulations. The supplements will be available for distribution to clients and partners worldwide via Avida Labs, Avida's white-labelling and manufacturing business.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Compass Pathways Announces Third Quarter 2024 Financial Results and Business Updates

  • Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression now expected in second quarter 2025
  • COMP006 data will now be announced after 26-week time point, expected in the second half of 2026
  • Strategic reorganization to focus all efforts on COMP360 program resulting in reduction of workforce of approximately 30%
  • Cash position of $207 million
  • Conference call October 31 at 8:00 am ET (12:00 pm UK)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2024 and an update on recent business progress.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Emyria Limited

Emyria and UWA in Partnership to Commercialise Novel Serotonin-Releasing Agents for Mental Health and Neurology

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) has signed an exclusive licence agreement with UWA, granting worldwide rights to a rapidly growing portfolio of selective serotonin-releasing agents. (See Appendix for Key Commercial Terms). These novel compounds, realised through a UWA–Emyria research partnership launched in 2021,2 include potential next-generation treatments for mental health and neurological conditions such as PTSD and Parkinson’s disease.

Keep reading...Show less

Seelos Announces Second Postponement of its Annual Meeting of Stockholders

Seelos Therapeutics, Inc. (OTCQB: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was previously postponed to Friday, October 25, 2024 from its originally scheduled date of Friday, September 27, 2024 has been further postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Monday, November 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting, August 19, 2024 is unchanged and applies to the postponed Annual Meeting.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Compass Pathways to Announce Third Quarter Financial Results on October 31, 2024

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the third quarter 2024 ending September 30, 2024, and provide an update on recent business developments, on October 31, 2024.

The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Quantum Biopharm (CSE: QNTM)

Quantum BioPharma Files a US Federal Lawsuit Against CIBC World Markets, RBC Dominion Securities and Others, Seeking Damages in Excess of $700,000,000 USD, for Possible Stock Price Manipulation/Spoofing

Christian Attar Law Firm and Freedman Normand Friedland LLP, in conjunction with forensic investigators, have uncovered evidence of a potential multi-year market manipulation scheme that has caused substantial damages to the Company and its shareholders


Keep reading...Show less

Latest Press Releases

Related News

×