PsyBio Therapeutics Initiates European Manufacturing of Proprietary Biosynthetic Psychedelic Compounds including Psilocybin with France-based Biose Industrie
PsyBio Therapeutics Corp.(CVE: PSYB)(OTCMKTS: PSYBF), an intellectual property driven biotechnology company researching and developing novel formulations of psychoactive medications produced by genetically modified bacteria for the potential treatment of mental health challenges and other disorders, has initiated its first, European pilot scale batch manufacturing of its psychedelic portfolio of compounds with the proprietary biosynthetic formulation of psilocybin in collaboration with Biose Industrie (“Biose“), an expert in commercializing pharmaceutical products based on live bacterial production, to prepare products and substances for ongoing regulatory evaluation.
“In our effort to expand our clinical development beyond North America, we are pleased to be working with Biose, a highly competent company operating under a Good Manufacturing Practices (“GMP“) certified facility located in Aurillac, France, for the manufacturing of our bacteria-based drug substance and drug products in the European Union (“EU“) for further pre-clinical and clinical scientific evaluation,” said Evan Levine, Chief Executive Officer of PsyBio. “Biose has over 70 years of experience in commercializing therapeutics developed and produced utilizing live bacterial strains.”
It was a critically important strategic initiative for PsyBio to leverage our proprietary methods of production within the EU. Biose is the ideal partner for us in the EU with extensive expertise and capability to not only produce individual therapies in a regulatorily compliant manner, but to also facilitate the development and testing of combination therapies. Our partnership with Biose will further our research and development goals and demonstrate our commitment to the development of globally-tested and approved therapeutics.Dr. Michael Spigarelli, Chief Medical Officer of PsyBio.
Further to the Company’s press release dated June 1, 2021, the Company has settled US$125,144.48 of accrued liabilities owing for professional services provided to the Company by a non-arm’s length party through the issuance of 409,752 subordinate voting shares of the Company (“Shares“). The Shares were issued at a deemed price of thirty-seven cents Canadian per Share. The Shares were issued in reliance on certain prospectus exemptions available under securities legislation and are subject to a four-month statutory hold period expiring October 22, 2021. Pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101“), this transaction constitutes a “related party transaction” as the creditor is considered a related party of the Company. The Company is relying on exemptions from the formal valuation and minority approval requirements of MI 61-101 (pursuant to subsections 5.5(a) and 5.7(a)) as the fair market value of the securities distributed to, and the consideration received from, the related party does not exceed 25% of the Company’s market capitalization. The debt settlement transaction was approved by all the independent directors of the Company.
In accordance with the disclosure policies of the TSXV, the Company also announces that it has entered into a six month consulting agreement (the “Consulting Agreement“) with North Equities Corp. (“North Equities“), a marketing firm based in Toronto, Canada. North Equities has been engaged to increase the awareness of the Company to prospective investors and expand the Company’s current social media presence. In accordance with the terms of the Consulting Agreement, as compensation for North Equities’ services, the Corporation has agreed to pay a cash fee of seventy thousand dollars Canadian, half of which was paid upon signing of the Consulting Agreement (the “Effective Date“), and half of which will be paid 90 days following the Effective Date.
To view the original press release in its entirety click here