Mr. Bill Ciprick reports
OPTIMI HEALTH RECEIVES CERTIFICATE OF ANALYSIS FOR MDMA 40MG AND 60MG GMP CAPSULES
Optimi Health Corp. has received a certificate of analysis (COA) from independent third party laboratory testing, confirming that Optimi's formulated MDMA (3,4-methylenedioxy-N-methamphetamine) meets good manufacturing practice (GMP) specifications.
Optimi has also completed GMP process validation for the encapsulation of the active pharmaceutical ingredient (API) in both 40-milligram (mg) and 60 mg dosage formats for batch sizes up to 1,000 capsules during GMP production.
The COA for the finished product affirms important data and analytics around content uniformity, microbial and water content, and dosage strength. Additionally, Optimi's continuing stability testing demonstrated that the MDMA API used to make both dosages remains stable within the capsules under both real-time and accelerated storage conditions for up to three months.
Dr. Preston Chase, Optimi's chief science officer, stated: "Our team's attention to detail enabled us to achieve releasable MDMA capsules that not only meet regulatory and GMP compliance, but also exceed expectations in terms of dosage uniformity, dissolution and stability. We are thrilled to be one of the only companies in the world with MDMA 40 mg and 60 mg GMP capsules now available."
The MDMA API used to produce the releasable GMP capsules has a purity level of 99.95 per cent.
Bill Ciprick, chief executive officer of Optimi, stated: "Our dedication to quality and reliability drives every aspect of our operation. Completing the process validation and stability testing underscores our commitment to producing drug candidates that adhere to the highest GMP standards of consistency and reliability."
Corporate update
Optimi is pleased to announce that it intends to close a third and final tranche of its non-brokered private placement.
The offering consists of units at 30 cents per unit for gross proceeds of up to $1.5-million. Optimi raised $555,010, which closed Feb. 23, 2024, and $400,000, which closed May 10, 2024 (the second tranche).
Each unit is composed of one common share in the capital of the company and one-half of one transferable common share purchase warrant. Each warrant entitles the holder to acquire one common share at 40 cents for two years from the date of issuance, subject to an accelerated expiry provision, whereby, in the event the closing price of the company's common shares on the Canadian Securities Exchange exceeds 50 cents for a period of 20 consecutive trading days, at the company's election, the period within which the warrants are exercisable will be reduced and the holders of the warrants will be entitled to exercise their warrants for a period of 30 days commencing on the day the company provides notice; any outstanding warrants not exercised during the 30-day period will expire. The company intends to use the net proceeds from the offering to obtain its drug establishment licence, facilitate commercialization, and for general working capital.
The second tranche included participation from directors J.J. Wilson and Dane Stevens, and constituted a related-party transaction as defined in Multilateral Instrument 61-101 -- Protection of Minority Securityholders in Special Transactions as they acquired an aggregate of 1,333,334 units. Following the acquisition, Mr. Wilson, chair of the board and a director, holds 7,674,167 common shares, or 8.48 per cent of the company, and Mr. Stevens, chief marketing officer and a director, holds 9,667,900 common shares, or 10.68 per cent of the company. The company is relying on the exemptions from the valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101, as the fair market value of the participation in the offering by the insiders does not exceed 25 per cent of the market capitalization of the company, as determined in accordance with MI 61-101.
All securities issued under the second tranche, including securities issuable on exercise thereof, are subject to a hold period expiring Sept. 11, 2024, in accordance with the rules and policies of the exchange and applicable Canadian securities laws.
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 3,4-methylenedioxymethamphetamine (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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