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PsyBio Therapeutics Augments Intellectual Property Portfolio with Filing of Next Novel Psychedelic Compositions and Methods of Treatment Patent

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Intellectual property portfolio now includes five pending provisionals and one pending non-provisional patent application

OXFORD, Ohio and COCONUT CREEK, Fla., July 13, 2021 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTC: PSYBF) ("PsyBio" or the "Company"), 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, has filed a new provisional patent application with the United States Patent and Trademark Office entitled Psilocybin and Norbaeocystin Compositions and Methods of Treatment (the "Patent Application"). The Patent Application contains 67 new inventive claims and further demonstrates the Company's vision to build a strong intellectual property portfolio protecting numerous novel psychedelic drug candidates being developed for clinical trial evaluations.

PsyBio's intellectual property portfolio now includes five pending provisionals and one pending non-provisional patent application.

"PsyBio is uniquely positioned as one of the leading biotechnology companies sponsoring the development of new therapeutic targets for myriad human health conditions," stated Evan Levine, Chief Executive Officer of PsyBio. "PsyBio has a multifaceted, biotechnology focused development program spanning compounds from different plants and fungi as well as a discovery program for a variety of non-natural drug targets. We have successfully tech transferred the first two molecules from the bench to commercial manufacturing and will continue with additional product candidates in the coming months. We are planning on submitting PsyBio's initial pre-Investigational New Drug Application request by the end of this quarter with the goal of filing an Investigational New Drug Application around the end of 2021."

"The discovery of promising new tryptamine combinations can benefit from formal scientific evaluation in rodent models to define their potential therapeutic benefits," stated Dr. Matthew S. McMurray, PhD, Member of PsyBio's Scientific Advisory Board and Assistant Professor of Psychology at Miami University in Oxford, Ohio. "Results from our latest testing demonstrates preliminary enhancement of efficacy when compounds are combined. This suggests powerful synergies exist between certain tryptamines, which may herald improved therapeutic profiles and safety. The collaboration agreement with PsyBio has expedited testing of these novel tryptamine combinations in my laboratory."

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.

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 ability of PsyBio to develop novel formulations to treate mental health challenges and ther disorders; and the ability of PsyBio to submit an initial pre-Investigational New Drug Application request by the end of this quarter and an Investigational New Drug Application by the end of 2021.

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; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file its initial pre-Investigational New Drug Application request and Investigational New Drug Application within anticipated timeframes; 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 TSX Venture Exchange ("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.

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View original content: http://www.newswire.ca/en/releases/archive/July2021/13/c1295.html