OXFORD, Ohio and COCONUT CREEK, Fla., Aug. 30, 2021 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company developing novel formulations of psychoactive drugs produced by genetically modified bacteria and other innovative mediums for the potential treatment of mental health challenges and other neurological disorders, today reported its unaudited financial results for the three-month period ended June 30, 2021 and provided shareholders with a corporate update.
Second Quarter 2021 Financial Results
A copy of the unaudited condensed consolidated interim financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management's discussion and analysis for the three months ended June 30, 2021, can be found under PsyBio's profile at www.sedar.com.
Intellectual Property and Clinical Development Milestones
- The Company initiated a European pilot scale batch manufacturing of its psychedelic portfolio of compounds with the proprietary biosynthetic formulation of psilocybin in collaboration with Biose Industrie ("Biose") in Aurillac, France. The partnership with Biose will advance the Company's research and development goals and continue its endeavor to the development of globally-tested and approved therapeutics.
- The Company has filed the following patent applications with the United States Patent and Trademark Office (the "USPTO"), bringing the Company's intellectual property portfolio to seven, pending provisionals and one pending non-provisional patent application:
- PsyBio filed a new provisional patent application with the USPTO entitled Psilocybin and Norbaeocystin Compositions and Methods of Treatment which contains 67 new inventive claims. This new patent application results from the Company's latest testing demonstrating preliminary enhancement of efficacy when compounds are combined, suggesting powerful synergies exist between certain tryptamines which may signal improved therapeutic profiles and safety.
- The Company 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. Concurrently, the Company filed a new provisional patent application with the USPTO 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 and addiction as well as other psychological conditions.
- The Company filed a new provisional patent application with the USPTO entitled Methods for the Production of a Methylated Tryptamines and Intermediates or Side Products, adding additional methylated tryptamines including compounds such as N,N-Dimethyltryptamine (DMT) and associated analogs for development of potential treatments for a variety of human health conditions.
Corporate Finance Update
- The Company listed its Shares for trading on the OTCQB Venture Market (the "OTCQB") at the market open on July 14, 2021 under the symbol "PSYBF". The listing on the OTCQB positions PsyBio with increased visibility among the U.S.-based investment community, and is intended to improve liquidity for the Company's current and prospective shareholders.
- The Company recently announced TSX Venture Exchange ("TSXV") approval of a sharebuyback program (the "Share Buyback Program") for up to 2,983,951 subordinate voting shares in the capital of the Company (the "Shares"), representing five percent of the issued and outstanding Shares, and the entering into of a dealer agreement and automatic share purchase plan (the "ASPP") with Haywood Securities Inc. in respect of the Share Buyback Program. While the Company has acquired no Shares since the Sharebuyback Program became effective on June 30, 2021, management of the Company and the Board of Directors of the Company continue to believe that the current market price of the Shares does not adequately reflect their value. The Company will continue to consider making purchases through the facilities of the TSXV, subject to the terms and conditions set forth in the ASPP.
About PsyBio Therapeutics Corp.
PsyBio Therapeutics is an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health challenges and other disorders. 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 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 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; 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 competive 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 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; 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 United States Food and Drug Administration ("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 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.