OXFORD, Ohio and DENVER, Nov. 29, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), a fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announced that it has reported its unaudited interim financial results for the three and nine month period ended September 30, 2022.
Third Quarter 2022 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 and nine months ended September 30, 2022, can be found under PsyBio's profile on SEDAR at www.sedar.com.
Intellectual Property and Clinical Development Milestones
- The Company recently announced that it has reached an initial agreement with experienced clinical researchers to conduct a clinical trial utilizing PsyBio's proprietary biosynthetic psilocybin product upon obtaining all necessary approvals and licenses.
- The Company recently announced the formal acceptance by the United States Patent and Trademark Office of its latest U.S. PCT (Non-Provisional) Patent Application.
- The Company plans to communicate additional patent filings and conversions before the end of 2022, and expects to bring its total US Patent Applications to twenty nine, US Provisional Applications to nineteen, and US PCT Non-provisional Applications to ten.1
About PsyBio Therapeutics Corp.
PsyBio Therapeutics is an intellectual property driven biotechnology company 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.
1 This is forward-looking information and is based on a number of assumptions, which include that PsyBio will be successful in making additional patent filings and conversions before the end of 2022 and protecting its intellectual property. See "Cautionary Note Regarding Forward-Looking Statements".
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 proceed with clinical development and to build on efforts to potentially improve mental and neurological healthcare for patients; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the success of PsyBio's novel methodology; the ability of PsyBio to build and protect its intellectual property portfolio of novel drug candidates; the ability of PsyBio to launch clinical trials; 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: the patent information submitted will support and allow PsyBio's novel methodology to be successful; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more investigational new drug applications with the United States Food and Drug Administration ("FDA"); PsyBio will be successful in obtaining 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.