PsyBio Therapeutics Initiates European Manufacturing of Proprietary Biosynthetic Psychedelic Compounds including Psilocybin with France-based Biose Industrie
June 22nd, 2021
COCONUT CREEK, Fla., June 22, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTC: PSYBF) (“PsyBio” or the “Company“), 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,” stated 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.
About PsyBio Therapeutics Corp.
PsyBio Therapeutics is an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health challenges and other disorders. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new non-naturally occurring molecular structures which may have unique therapeutics properties.
About Biose Industrie
Biose is a contract development and manufacturing organization, specialized in live biotherapeutic products. Founded in 1951 by pharmacists and microbiologists, Biose has more than 60 years of experience in the development and production of live bacteria-based drugs. Biose offers research and development for molecular biology and process development and GMP production of drug substance and drug product at both clinical and commercial levels.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information.
In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio’s technology will be safe and effective; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.
PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.
The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
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