PsyBio Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update on Intellectual Property and Clinical Development Milestones
OXFORD, Ohio and COCONUT CREEK, Fla., Nov. 30, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (” PsyBio ” or the ” Company “), an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced that it has reported its unaudited financial results for the interim period ended September 30, 2021 and provided shareholders with a corporate update.
Third 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 interim period ended September 30, 2021, can be found under PsyBio’s profile at www.sedar.com .
Intellectual Property and Clinical Development Milestones
- The Company furthered its intellectual property portfolio by filing six additional manufacturing patent applications with the United States Patent and Trademark Office (the ” USPTO “) that cover a broad range of approaches to PsyBio’s biologic methodology as it pertains to the current landscape of biotechnology.
- The Company successfully demonstrated the ability to manufacture PsyBio-11040, one of its first promising therapeutic candidates, at commercial scale.
- The Company submitted a pre-Investigational New Drug (” IND “) Application request to the United States Food and Drug Administration (” FDA “) seeking guidance on data necessary to warrant an IND submission.
- The Company filed a provisional patent application with the USPTO entitled Psilocybin and Norbaeocystin Compositions and Methods of Treatment, which contained 67 new inventive claims.
- The Company filed a provisional patent application with the USPTO entitled NMDA Receptor Antagonist-Containing Compositions and Methods of Treatment and 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.
Corporate Finance Update
- The Company filed and obtained receipts for a final base shelf prospectus dated October 28, 2021, which is expected to help facilitate institutional investor access to the Company’s securities.
- The Company’s subordinate voting shares were made eligible for electronic clearing and settlement through the Depository Trust Company (” DTC “) in the United States , which is anticipated to benefit investors with increased liquidity and execution speed.
- The Company was included in AdvisorShares Psychedelics Exchange Traded Fund, which is listed on the NYSE Arca under the ticker symbol (NYSE: PSIL) and was formed to actively manage investments in the emerging psychedelic drugs sector.
The Company’s subordinate voting shares commenced trading on the OTCQB Venture Market at market open on July 14, 2021 under the symbol “PSYBF”. - The Company purchased an aggregate of 397,500 subordinate voting shares under its normal course issuer bid (” NCIB “) during the month of October 2021 , at an average price of $0.314 per share. All shares purchased under the NCIB were cancelled.
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: 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 competitive synthesis with reduced environmental impact over current production methods; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the impact of DTC eligibility on existing and prospective investors’ ability to trade the Company’s subordinate voting shares; and the impact of DTC eligibility on the liquidity of the Company’s subordinate voting shares.
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-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 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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