PsyBio Therapeutics Adds NMDA Receptor Antagonists and Associated Analogues into its Intellectual Property Portfolio

PsyBio has filed a new provisional patent and is initiating preclinical studies aimed at treating neurologic and psychologic conditions

COCONUT CREEK, Fla, Aug. 4, 2021 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria and other innovative mediums for the potential treatment of mental health challenges and other neurological disorders, has initiated a new program to study N-methyl-D-aspartate ("NMDA") receptor antagonists and associated analogs for potential activity against a variety of human health conditions.

The Company has filed a new provisional patent application with the United States Patent and Trademark Office entitled NMDA Receptor Antagonist-Containing Compositions and Methods of Treatment. The addition of NMDA receptor antagonists with pending patent protection is highly focused on the potential improvement of neurological conditions including traumatic brain injury, other neurological deficits, addiction as well as other psychological conditions.

NMDA receptor antagonists play an important role in the health and function of neurons and have been implicated by a number of studies to be strongly involved with exitotoxicity and also associated with promoting synaptic plasticity. Research also indicates that some NMDA receptor antagonists also interact with nicotinic acetylcholine receptors leading to the release of neurotransmitters. Many compounds in this class have been approved by the United States Food and Drug Administration ("FDA") as anesthetics and are under evaluation for other indications within the brain.

The scientific discovery, clinical pharmacology and drug development team at PsyBio has identified NMDA receptor antagonists and their analogues for their role in promoting neuroplasticity as potential therapeutic targets for a wide variety of disease indications. PsyBio continues utilizing its resources to rapidly develop and test new drug candidates in anticipation of launching future clinical trials.

"PsyBio is distinctively positioned as one of the leading biotechnology companies sponsoring commercial development of new therapeutic targets for myriad human health conditions," stated Evan Levine, PsyBio's Chief Executive Officer. "The Company is actively screening drug candidates across a variety of medical indications and will utilize its regulatory experience to submit proposals for human clinical trials based upon those preclinical studies to the FDA and other regulatory bodies. The Company retains expertise across a wide range of pharmaceutical discovery and development including synthetic biology, molecular engineering, neurobiopsychology, translational medicine and clinical pharmacology and is leveraging this ability to work towards shepperding new therapeutics to treat unmet medical needs."

"PsyBio has unique expertise in clinical pharmacology and is actively expanding its portfolio of drug candidates and remains particularly interested in advancing therapeutic understanding and potential treatment of neurologic and psychologic conditions," stated Dr. Michael Spigarelli, PsyBio's Chief Medical Officer. "The advantages of utilizing compounds, exhibiting previously known neurological or psychological effect, to harness the opportunity to develop potential therapeutics more rapidly than previously conceived."

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

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing novel formulations of psychoactive medications for the potential treatment of neurologic and psychologic conditions. 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 NMDA receptor antagonists.

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 potentially treat neurologic and psychologic conditions and other disorders; and the ability of PsyBio to launch clinical trials.

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 ("IND")  Application request and IND Application within anticipated timeframes; PsyBio will be successful in obtaining IND Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching 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 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.

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