PsyBio Therapeutics Establishes Research and Development Laboratory to Facilitate Portfolio Development Progress

PsyBio Therapeutics Expands Upon Previously Established Research Collaboration with Miami University

OXFORD, Ohio and COCONUT CREEK, Fla., Jan. 5, 2022 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced that it has expanded its ongoing relationship with Miami University in Oxford, Ohio ("Miami University") by leasing dedicated research and development ("R&D") laboratory space.

The laboratory space at Miami University is expected to provide a comprehensive, state-of-the-art research environment in which PsyBio's ever-expanding portfolio of compounds can be more readily and rapidly developed. This continued collaboration with Miami University is anticipated to expedite progress toward PsyBio filing an Investigational New Drug ("IND") application with the United States Food and Drug Administration ("FDA").

"Establishing this R&D laboratory is a critically important development for PsyBio, which is expected to allow pre-manufacturing and production process optimization," stated Michael Spigarelli, M.D., Ph.D., MBA, PsyBio's Chief Medical Officer. "The laboratory will allow us to expedite the Chemistry Manufacturing and Controls (CMC) development processes as part of PsyBio's Quality by Design (QbD) strategy to produce psycho-targeted therapeutics intended to improve mental and neurological health."

PsyBio acquired the global, exclusive, and perpetual right to license the platform technology developed at Miami University enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria.  The Company announced that it had successfully demonstrated commercial scale manufacturing feasibility for one of its first promising compounds in October 2021.

"We are pleased that PsyBio has chosen to establish R&D laboratory space here at Miami University and further its collaboration with our renowned faculty and amazing students," said Gregory Crawford, President of Miami University. "Having PsyBio on campus will provide additional research opportunities for our faculty and students, while also shortening the bench-to-bedside timeline of therapeutics that could potentially improve mental health."

Intended to foster university and industry partnerships, the laboratory space is expected to be used to transition the intellectual property and findings from basic research to the commercialization stage. PsyBio currently funds research of J. Andrew Jones in Miami University's department of chemical, paper and biomedical engineering, and Matthew McMurray in the department of psychology. 

"We are fortunate to have secured this state-of-the-art research facility to further demonstrate our commitment to produce a variety of psycho-targeted therapeutic candidates as one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds," stated Evan Levine, PsyBio's Chief Executive Officer. "We anticipate that the establishment of this laboratory will allow PsyBio to continue to develop its licensed technology. The laboratory is an extension of our ongoing support and collaboration with Miami University."

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 ability of PsyBio to establish a dedicated R&D laboratory at Miami University; the anticipated benefits of the laboratory on PsyBio's R&D activities; the ability of PsyBio to successfully file an IND application with the FDA; 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 successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in filing IND 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 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 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.

SOURCE PsyBio Therapeutics Corp.

Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: [email protected]; Investor Enquiries: Valter Pinto or Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: [email protected]