OXFORD, Ohio and COCONUT CREEK, Fla., March 2, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has reported its audited financial results for the year ended December 31, 2021.
Annual 2021 Financial Results
A copy of the audited condensed consolidated annual financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysis for the year ended December 31, 2021, can be found under PsyBio’s profile on SEDAR at www.sedar.com.
“PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry,” stated Evan Levine, Chief Executive Officer. “Our filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. The PsyBio team collectively has experience managing thousands of clinical trials and achieving hundreds of regulatory approvals related to therapeutics, diagnostics and devices. PsyBio has filed sixteen patent applications to date on its discovery accomplishments and is looking forward to filing an Investigational New Drug (“IND“) application for its first biosynthetic therapeutic candidate and launching clinical trials this year.”
Fourth Quarter Development Milestones
- The Company sponsored sixteen collaborative research abstract presentations at two scientific conferences. These abstracts cover a wide variety of topics including: biosynthetic pathway and transcriptional methodologic development; evaluation; screening and optimization of systems and organisms; increasing bioproduction yields of natural and non-natural products, as well as the evaluation of impulsivity, motivational, psychiatric, and psychoactive effects of PsyBio’s portfolio of compounds.
- The Company successfully completed its first pre-IND meeting with the United States Food and Drug Administration (the “FDA“). 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.
- The Company established new research and development laboratories to facilitate portfolio development progress. The new 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 IND application with the FDA.
About PsyBio Therapeutics Corp.
PsyBio Therapeutics is a fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders and other human health 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 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, specifically because they are already known to have an effect within the brain.
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 anticipated benefits of the laboratory space at Miami University on PsyBio’s research and development activities; PsyBio’s plans to submit compound specific pre-IND meeting requests to the FDA to define manufacturing and clinical trial parameters; PsyBio’s plans and ability to file an IND application with the FDA within expected timeframes, if at all; PsyBio’s plans and ability to launch clinical trials within expected timeframes, if at all; the ability of PsyBio to develop novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions; the ability of PsyBio to build 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; the laboratories at Miami University will benefit PsyBio’s research and development activities; the continued collaboration with Miami University will expedite progress toward filing an IND application with the FDA; PsyBio will submit compound specific pre-IND meeting requests to the FDA; the FDA will grant such pre-IND meetings and the outcome of such meetings will be favourable; PsyBio will file one or more IND applications with the FDA; PsyBio 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 favorable; 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.