Dr. Spigarelli’s extensive clinical and research development expertise will be integral in leading PsyBio’s development and clinical goals

OXFORD, Ohio and COCONUT CREEK, Fla., April 5, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (“PsyBio“), a biotechnology company pioneering the next generation of targeted psychoactive medications, today announced the appointment of Michael Spigarelli, M.D., Ph.D., MBA, as Chief Medical Officer to lead the ongoing development of PsyBio’s drug discovery platform technology. Dr. Spigarelli brings his extensive expertise in research and development of biopharmaceuticals including the clinical and regulatory strategy for numerous mental health therapeutics and other conditions. Dr. Spigarelli will provide PsyBio with decades of clinical product development experience, including clinical trial design and execution, data analytics and presentation, regulatory approval, quality control and GXP project management.

“In this new role, Dr. Spigarelli will provide leadership and insight into clinical operations, research & development, regulatory and quality affairs and program management to lead product development of new psychoactive therapies,” stated Evan Levine, Chief Executive Officer of PsyBio. “Mike’s unique combination of skills, from treatment to therapeutic device and diagnostic product development, including numerous U.S. Food and Drug Administration (the “FDA“) and global regulatory approvals, will be critical for compiling pre-clinical data and clinical trial designs for IND submissions. We are excited to leverage his experience and demonstrate the full potential of our portfolio of psychoactive candidates as we move our products into clinical trials.”

“What excites me is the unique position PsyBio is in to potentially develop numerous, novel, and clinically-needed solutions for individuals and their families suffering from a variety of mental health conditions,” stated Michael Spigarelli. “I am eager to lead the Company’s development and advance its strong pipeline of products through clinical development into human studies and, subject to receipt of all necessary approvals, onto the global markets. Such products will be studied to determine the potential efficacy to positively impact patients lives by better managing their mental health conditions.”

In connection with the appointment of Dr. Spigarelli as Chief Medical Officer of the Company, the board of directors of the Company has approved the granting of options to Dr. Spigarelli to purchase up to two million subordinate voting shares in the capital of the Company, pursuant to the Company’s stock option plan. The options are exercisable at a price of $0.35 per share for a period of three years from the date of issuance.

 

About Dr. Michael Spigarelli

Before joining PsyBio Therapeutics, Dr. Spigarelli served as Chief Medical Officer for Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases. Prior to that, he served as Vice President of Medical Affairs for Immucor, Inc., a leading provider of transfusion and transplantation diagnostic products worldwide. During that time, he helped develop strategy and obtain FDA as well as global regulatory approval for numerous assays and reagents including monoclonal and polyclonal antibodies and has led assay development, clinical affairs, program management and regulatory & quality affairs with extensive experience in the U.S., EU and global product development and regulatory approval. Dr. Spigarelli previously served as Chair of the American Board of Clinical Pharmacology and worked directly with numerous late stage drug development companies on clinical trial design, site selection, KOL relationships, pharmacogenomics, pharmacometrics, pharmacology, due diligence evaluations and regulatory strategies. He began his career in academia, reaching the rank of Professor of Pediatrics, Internal Medicine and Pharmaceutics & Therapeutics having worked at several major universities developing infrastructure to improve clinical research and industrial partnership. Dr. Spigarelli received his MBA from the University of Utah, both his Ph.D. in Medicinal Chemistry, and his M.D. with distinction in research from the University of Michigan in Ann Arbor.

 

About PsyBio Therapeutics Corp.

PsyBio is a biotechnology company developing novel formulations of psychoactive medications 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 halucinogenic 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 the 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. 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 obtaining Investigation 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 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.

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PsyBio Strengthens its Leadership Team with Appointment of Dr. Michael Spigarelli as Chief Medical Officer