OXFORD, OH and DENVER, CO, May 30, 2022 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), a fully 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 announced that it has reported its interim financial results for the three month period ended March 31, 2022 and provided shareholders with a corporate update.
First 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 months ended March 31, 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 achieved a commercially scalable purification method for one of its second-generation compounds. This purification process methodology is a necessary component for the Chemistry, Manufacturing and Controls section ("CMC") for an Investigational New Drug ("IND") application with the United States Food and Drug Administration ("FDA").
- The Company recently announced that it expanded its preclinical pipeline activities by initiating blood-brain barrier permeability testing. Favorable results from this type of testing are anticipated to expediate compound selection and progress toward the filing of an IND application with the FDA.
- The Company recently announced that that it submitted an application to convert existing provisional patents to full patents. This submission covers major markets including North America, Europe, Asia-Pacific, and Africa as well as other important countries. The continued collaboration with Miami University is anticipated to expedite progress toward the filing of an IND application with the FDA.
- The Company recently announced that it is initiating the process of recruiting, evaluating, and selecting highly qualified investigators for upcoming clinical trials.
- The Company recently announced that it is in the process of drafting its second pre-IND application in anticipation of seeking IND approval from the FDA for clinical trials.
About PsyBio Therapeutics Corp.
PsyBio is an intellectual property driven biotechnology company developing new, bespoke, fully approved, 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, 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: PsyBio's plans for filing IND applications with the FDA; PsyBio's plans to submit a second pre-IND application to the FDA; the impact of PsyBio's recently announced purification process methodology achievement on the CMC section of PsyBio's IND application with the FDA; PsyBio's plans and ability to conduct successful blood-brain barrier permeability testing; the impact of favorable results from blood-brain barrier permeability testing on compound selection and progress toward the filing of IND applications with the FDA; the ability of PsyBio to convert existing provisional patents to full patents; the impact of continued collaboration with Miami University on progress toward the filing of IND applications with the FDA; PsyBio's ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio's plans to move towards clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health; PsyBio's ability to launch clinical trials; PsyBio's plans and ability to recruit clinical investigators for upcoming clinical trials; PsyBio's ability to build its intellectual property portfolio of novel drug candidates; PsyBio's ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and PsyBio's ability 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's recently announced purification process methodology will enable commercial scale purification of bioreactor produced products; this purification process methodology will have a positive impact on potential in vitro and in vivo testing; this purification process methodology will have a positive impact on progress toward the filing of IND applications with the FDA; blood-brain barrier permeability testing will yield favorable results; favorable results from blood-brain barrier permeability testing will have a positive impact on compound selection and progress toward the filing of IND applications with the FDA; PsyBio will be successful in recruiting highly qualified investigators for clinical evaluations; PsyBio will submit a second pre-IND application to the FDA; PsyBio will receive approval from the FDA to launch clinical trials; PsyBio will be successful in launching clinical trials; clinical investigators will be trained to conduct clinical investigations; clinical investigations will help facilitate rapid trial initiation and completion; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in submitting IND applications and will be able to obtain all necessary approvals for 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; and 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.