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PsyBio Therapeutics Successfully Completes First Pre-IND Meeting with the United States Food and Drug Administration

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PsyBio is committed to innovate, develop, and optimize technology related to its ever growing psycho-targeted portfolio through formal regulatory pathways

Based on feedback received, PsyBio intends to request its initial compound-specific pre-IND meeting

OXFORD, Ohio and COCONUT CREEK, Fla., Dec. 7, 2021 /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 successful completion of its initial pre-Investigational New Drug ("IND") application meeting with the United States Food and Drug Administration ("FDA") as part of the regulatory submission process.

PsyBio Therapeutics Corp. logo (CNW Group/PsyBio Therapeutics Corp.)
PsyBio Therapeutics Corp. logo (CNW Group/PsyBio Therapeutics Corp.)

"PsyBio was created to develop novel therapeutic candidates with the goal to help improve human health," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief Medical Officer. "To achieve this goal, regulatory approval for any potential therapeutic candidate is absolutely necessary to bring that product to the patients who may benefit. As such, it is critically important to have open discussions, such as this meeting, with regulatory officials to most efficiently and effectively follow all requirements and guidance to facilitate future approvals."

The focus of this pre-IND meeting was to discuss potential indications, manufacturing strategy, and obtain regulatory guidance as PsyBio guides its technology forward towards regulatory approval. The responses received from the FDA to these initial set of questions were constructive and no changes were proposed with respect to PsyBio's approach. Based upon this initial discussion, PsyBio intends to submit compound specific pre-IND meeting requests to define manufacturing and clinical trial parameters.

"This initial pre-IND meeting marks our formal entry into the regulatory process, which is paramount and of foremost importance to PsyBio as part of our commitment to being a leader in developing psycho-targeted therapeutic candidates," stated Evan Levine, PsyBio's Chief Executive Officer. "The FDA has provided invaluable guidance which the Company plans to heed and implement during the development period. We look forward to collaborating with the FDA and other regulatory agencies to demonstrate our potential therapeutic candidates are safe and effective for their proposed indications."

About PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company focusing on discovering and 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: PsyBio's plans to submit compound specific pre-IND meeting requests to the FDA to define manufacturing and clinical trial parameters; 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: 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 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.

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