PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa
OXFORD, Ohio and COCONUT CREEK, Fla., March 15, 2022 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has entered into a definitive agreement (the "Agreement") to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. ("Everest"), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the "Acquisition"). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.
PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio's abilities which encompass fully translational capabilities in its current scientific laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.
"Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief Medical Officer. "The next step is for PsyBio to collaborate with Everest's current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions."
Upon completion of the Acquisition, PsyBio will acquire Everest's active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.
"The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio's role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds," stated Evan Levine, PsyBio's Chief Executive Officer. "The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes."
The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the "SVS"), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange ("TSXV").
About PsyBio Therapeutics Corp.
PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. 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 activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of 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. Forward looking-statements in this press release include statements regarding: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.
In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; 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 will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio's technology will be safe and effective; a confirmed signal will be identified in PsyBio's selected indications; 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 U.S. 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.