01:42:30 EDT Fri 14 Jun 2024
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Optimi Health Corp
Symbol OPTI
Shares Issued 87,177,566
Close 2024-01-02 C$ 0.30
Market Cap C$ 26,153,270
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Optimi receives precursor licence to formulate MDMA

2024-01-03 10:25 ET - News Release

Mr. Jacob Safarik reports


Optimi Health Corp. has reached a significant milestone in the granting of its precursor licence for 3,4-methylenedioxyphenyl-2-propanone (MDP2P), the precursor used in the chemical synthesis of MDMA (3,4-methylenedioxy-N-methamphetamine).

Approved in December, 2023, by Health Canada under Section 16 of the Precursor Control Regulations, the licence allows Optimi to import MDP2P for the purpose of formulating and verifying MDMA drug candidates at the company's research and analytical facility in Princeton, B.C.

This achievement comes in the wake of a recent facility visit from Health Canada, serving as additional evidence of Optimi's firm commitment to regulatory compliance and operational excellence.

"Securing our precursor licence represents a pivotal advantage for Optimi, offering a compelling edge in producing MDMA at significantly reduced costs," said Jacob Safarik, Optimi's chief financial officer. "This strategic move aligns with our intent to address market demand for GMP (good manufacturing practice) MDMA in 2024, especially amid the heightened anticipation surrounding the recent new drug application (NDA) submission by the Multidisciplinary Association for Psychedelic Studies Public Benefit Corp. (MAPS PBC) to the United States Food and Drug Administration (FDA)."

Mr. Safarik also acknowledged another interesting development announced by the American Medical Association (AMA) yesterday, which Optimi is closely monitoring.

"With the AMA's current procedural terminology (CPT) III codes for psychedelic-assisted therapies now officially in effect, this underscores the goal of obtaining our precursor licence. With potential FDA approval, physicians and other qualified health care providers seeking coverage and reimbursement for delivering psychedelic-assisted therapy will now have a reliable partner who can formulate and encapsulate the most cost-effective, high-quality and accessible MDMA solutions in the market," he added.

Encapsulation milestone achieved

With the company's precursor licence secured, Dr. Preston A. Chase, Optimi's chief science officer, is pleased to report the successful encapsulation of MDMA into 40-milligram and 60 mg dosage formats after verification through its high-performance liquid chromatography (HPLC) methodology. This milestone further aligns Optimi strategically with the MAPS PBC's published protocol and recent NDA.

"This milestone is more than formulation. It symbolizes our dedication to achieving scientific uniqueness in alliance with industry pioneers such as the MAPS PBC who are paving the road ahead," said Dr. Chase. "Our innovation journey is grounded in advancing the safety and validity of our MDMA drug candidate, and I am happy to say that we're just hitting our stride in becoming the premier provider of fully verified, encapsulated MDMA in 2024 and beyond."

To prepare for the company's Australian supply agreements, continuous stability testing will be conducted to guarantee consistency and reliability. Optimi is set to obtain a certificate of analysis (COA) from a third party laboratory, confirming the purity and offering an extra layer of assurance to clients.

The company also announces it has issued 50,000 common shares, at a deemed price of 24.5 cents per share, subject to a hold period expiring May 3, 2024, in consideration of services provided.

About Optimi Health Corp.

Optimi Health is an end-to-end drug researcher and formulator licensed by Health Canada to produce and supply, for clinical research purposes, psychedelic substances such as MDMA, natural GMP-grade psilocybin, 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 No. 1 trusted, compassionate supplier of safe drug candidates throughout the world. Optimi's products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, B.C.

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