PsyBio Therapeutics Takes Initial Step to Help Protect the Sonoran Desert Toad as it Files Three New Provisional Patent Applications, Including Intellectual Property Protection for the Biosynthetic Production of 5-MeO-DMT

PsyBio continues to demonstrate its Environmental, Social, and Governance (ESG) commitment while increasing its presence in the psycho-targeted biosynthesis intellectual property space and remains strongly committed to innovation, development, and technology optimization

OXFORD, Ohio and DENVER, Dec. 8, 2022 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company focused upon discovery and development of new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced the filing of three additional U.S. Provisional Patent Applications covering its latest discoveries. This bring the total number of provisional applications filed by PsyBio to nineteen.

The National Park Service posted a request recently warning visitors not to lick the Sonoran Desert Toad (Incilius alvarius), as reported online by the Smithsonian Magazine.¹ The report describes that widespread use of 5-MeO-DMT could have disastrous effects for Sonoran Desert Toads and, as a result, that conservationists are urging people to use synthetic alternatives.¹

"The call for a synthetic alternative for 5-MeO-DMT highlights the intrinsic potential value of PsyBio's platform technology as it facilitates the biosynthetic production of these types of molecules.  Biosynthesis is a more environmentally sound, faster, and cost-effective way to manufacture these types of molecules than chemical synthesis without endangering any species of toad or other natural creature," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief Medical and Chief Scientific Officer.  "These additional patent filings demonstrate PsyBio's commitment to developing and protecting intellectual property with respect to biosynthetic tryptamine and phenylethylamine production for the development of psycho-targeted molecules as novel therapeutic candidates while protecting our environment and the many species living across the globe."

The three provisional patent applications comprise advancements concerning production methodology, host strains and processes of production that further support and allow PsyBio's novel production platform methodology to be patent protected including Intellectual Property Protection for the Biosynthetic Production of 5-MeO-DMT, which is environmentally safer than synthetic production methodology.  These filings demonstrate the company's commitment to value creation, while both promoting scientific and methodologic advancements in the field and demonstrating its Environmental, Social, and Governance (ESG) commitment.

"PsyBio has long been interested protecting the environment by developing biosynthetic methodology that we believe is less toxic and safer to all species that share our planet.  It continues ongoing strategic efforts to comprehensively cover the biosynthetic landscape for the development of psycho-targeted therapeutic candidates with the goal to improve mental and neurological health," stated Evan Levine, PsyBio's Chief Executive Officer. "With these provisional application filings, PsyBio furthers its leadership role within this field insuring intellectual property protection, critical for PsyBio and ultimately important for our investors as well as the environment."

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. 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 utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.

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 impact and ability of PsyBio's patent filings to protect the Sonoran Desert Toad; 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 and protect its intellectual property portfolio of novel drug candidates; 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: the protection of the Sonoran Desert Toad calls for a synthetic alternative for 5-MeO-DMT; PsyBio will be successful in developing a synthetic alternative for 5-MeO-DMT; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more IND Applications with the FDA; PsyBio will be successful in obtaining all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; 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 United States 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 (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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