Published on
May 12, 2021

PsyBio Therapeutics Increases Intellectual Property Portfolio with Filing of Novel Genetic Optimization Pathways for Psychedelic Medication Biosynthesis

Patent portfolio now includes four pending provisionals and one pending non-provisional patent application

OXFORD, Ohio and COCONUT CREEK, Fla., May 12, 2021 /CNW/ -- PsyBio Therapeutics Corp. (TSXV: PSYB) (OTC Pink: PSYBF) ("PsyBio"), an intellectual property based biotechnology company pioneering the next generation of targeted psychoactive medications, announced today that it has filed a new provisional patent application with the U.S. Patent and Trademark Office entitled Optimized Methods for the Production of Psilocybin and its Intermediates or Side Products. This filing increases the Company's licensed patent portfolio to four pending provisional patents and one pending non-provisional patent with the U.S. Patent and Trademark Office as the Company continues to build its platform around bacterial-based synthesis of therapeutic tryptamines.

Psychedelics have shown promise for the potential treatment of a myriad of health challenges including mental health disorders such as post-traumatic stress disorder, anxiety, treatment resistant depression, and addiction. These small biomolecules are difficult to mass produce through chemical means or through extraction from the native organism. By utilizing genetically modified bacteria, PsyBio has developed a patent pending methodology to produce high concentrations of targeted potential therapeutics through fermentation with the goal of developing them for potential human therapy. The Company is tech transferring the first two of its lead compounds, psilocybin and norbaeocystin, into process development and scaled manufacturing.

"By building upon PsyBio's platform technology, we are in a unique position to leverage the value of naturally occurring tryptamines by utilizing their innate synergy to build potentially improved therapeutics targeted across a wide range of health challenges," stated Dr. Michael Spigarelli, Chief Medical Officer of PsyBio. "Based on the established literature, successful preclinical results, and recent technology transfer to globally acclaimed development facilities, we are preparing the first of several packages for submission to the U.S. Food and Drug Administration (the "FDA") in the coming quarter in anticipation of upcoming clinical trials."

"PsyBio has assembled, by hiring and collaboration, a premier team of engineers, scientists and regulatory experts dedicated to discovery, optimization, and development of new therapeutics based on tryptamine inspired molecules for a myriad of health challenges," stated Evan Levine, Chief Executive Officer of PsyBio. "We continue to utilize sound scientific methodologies to discover new potential medications by resourcing our areas of expertise in metabolic engineering, chemistry, biology, and neuropsychology. The team has published and filed intellectual property on the most efficient methods to produce tryptamine compounds based on published data and continually builds on progress through targeted research and development efforts with the Jones and McMurray Labs at Miami University."

About PsyBio Therapeutics Corp.
PsyBio is a biotechnology company developing novel psychoactive therapeutics produced by genetically modified bacteria for the treatment of mental health and other disorders. The team has experience in drug discovery based on synthetic biology as well as clinical and regulatory experience moving 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, phenethylamines, and combinations thereof. The Company is also researching and developing new non-natural chemical entities which may have unique therapeutics properties.

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 forwardlooking 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 protecting its intellectual property and filing new patent applications within the next year; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in collaborating with the Jones and McMurray Labs; 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 forwardlooking 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 forwardlooking 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 FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products have 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 TSX Venture Exchange (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.

SOURCE PsyBio Therapeutics Corp.