CEO, Evan Levine, to Host 'Revolutionizing Psychedelic Medicine' Webinar on Wednesday, June 2nd at 1 p.m. ET
OXFORD, Ohio and COCONUT CREEK, Fla., June 1, 2021 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTC: PSYBF) ("PsyBio" or the "Company"), a biotechnology company pioneering the next generation of targeted psychoactive medications, is announcing its unaudited financial results for the three month period ended March 31, 2021, providing shareholders with an update, and announcing its intention to institute a share buyback program pending approval from the TSX Venture Exchange (the "TSXV").
First 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 March 31, 2021, can be found under PsyBio's profile at www.sedar.com.
Upcoming Webinar 'Revolutionizing Psychedelic Medicine'
CEO, Evan Levine, will host a virtual investor luncheon on Wednesday, June 2nd at 1 p.m. ET, in respect of revolutionizing psychedelic medicine.
The webinar will provide an inside look at PsyBio's innovations in the field of psychedelic medicine and is open to both investors and the public. Please register for the webinar via the following link:
Intellectual Property and Clinical Development Milestones
- Filed a new provisional patent application with the U.S. Patent and Trademark Office entitled Optimized Methods for the Production of Psilocybin and its Intermediates or Side Products, increasing the Company's licensed patent portfolio to four pending provisional patents and one pending non-provisional patent with the U.S. Patent and Trademark Office as the Company continues to build its platform around bacterial-based synthesis of therapeutic tryptamines.
- Amended its master sponsored agreement with Miami University based in Oxford, Ohio to extend and expand the research efforts of the laboratory of Dr. J. Andrew Jones in the Department of Chemical, Paper, and Biomedical Engineering, to include additional research efforts of the laboratory of Dr. Matthew McMurray in the Department of Psychology, and to provide an additional US$1.5 million in funding until May 2023 to Miami University to support all such research. This continued collaboration with Miami University is anticipated to expediate progress towards the filing of an Investigational New Drug Application with the US Food and Drug Administration ("FDA").
- Initiated process development of its proprietary biosynthetic formulation of norbaeocystin in collaboration with the Advanced Biofuels and Bioproducts Process Development Unit, a scale-up facility managed by Lawrence Berkeley National Laboratory, a U.S. Department of Energy national laboratory. Norbaeocystin is an analogue of psilocybin and is not a controlled substance. The Company has commenced Phase I of this process, including analytical chemistry technical transfer to establish detection methods for fermentation products and key feedstocks and metabolites.
- Initiated pilot scale-up of its proprietary biosynthetic formulation of psilocybin in collaboration with Albany Molecular Research Inc., a leading global provider of advanced contract research, development and manufacturing solutions, with expertise in synthetic biology and fermentation development. The Company has completed Phase I of this process, including technology transfer activities, preparation of strain banks, and the adoption of analytical methods.
Key Additions to Executive Management Team and Board of Directors
- Appointed Michael Spigarelli, M.D., Ph.D., MBA, as Chief Medical Officer to lead the ongoing development of PsyBio's drug discovery platform technology. Dr. Spigarelli brings his extensive expertise in research and development of biopharmaceuticals including the clinical and regulatory strategy for numerous mental health therapeutics and other conditions. Dr. Spigarelli will provide PsyBio with decades of clinical product development experience, including clinical trial design and execution, data analytics and presentation, regulatory approval, quality control and GXP project management.
- Appointed Mr. Bob Oliver to the Company's board of directors. Mr. Oliver has extensive experience in launching pharmaceutical products into global markets, offering invaluable depth for PsyBio. Mr. Oliver served as President and Chief Executive Officer of Otsuka America Pharmaceutical, and delivered a US$6 billion profit and loss statement, while managing a diverse and growing product portfolio across the cardio-renal, neuroscience, oncology, and medical device markets.
Recent Corporate Initiatives
- Submitted an application to have its subordinate voting shares (the "SVS") listed for trading on the OTCQX® Best Market (the "OTCQX"), subject to the approval of the OTCQX and the satisfaction of applicable listing requirements, including the Company's application for Depository Trust Company eligibility to enable trading on the OTCQX. The Company has also submitted an application to the OTCQX® Venture Market (the "OTCQB", and together with the OTCQX, the "OTC Markets").
- The Company intends to commence a normal course issuer bid (the "NCIB") through the facilities of the TSXV. The implementation and commencement of the NCIB is subject to the approval of the TSXV. Upon receipt of such approval, additional details regarding the NCIB will be announced by the Company.
- Under the NCIB and upon receiving regulatory approval, the Company may purchase up to 5% of the Company's issued and outstanding SVS. The NCIB will terminate on the earlier of one year from commencement or on the date in which the maximum number of SVS that can be acquired pursuant to the NCIB have been purchased. The actual number of SVS that may be purchased under the NCIB and the timing of any such purchases will be determined by the Company. PsyBio believes that depending on the trading price of its SVS and other relevant factors, purchasing its own shares represents an attractive investment opportunity and is in the best interests of the Company and its shareholders.
- PsyBio reserves the right to revoke the NCIB earlier if it determines that it is appropriate to do so. All SVS will be purchased under the NCIB on the open market and through the facilities of the TSXV and payment for the SVS will be made in accordance with TSXV policies. The timing and extent of repurchases will depend upon several factors, including market and business conditions, valuation of shares, regulatory requirements and other corporate considerations. The price paid for SVS will be the prevailing market price at the time of purchase and all SVS acquired by the Company will be cancelled. Purchases may be suspended at any time, and no purchases will be made other than by means of open market transactions during the term of the NCIB.
- The Company announces today that it has agreed to issue SVS to settle US$125,144.48 of accrued liabilities owing for professional services provided to the Company by a non-arm's length party at a deemed issuance price equal to the greater of C$0.35 per SVS and the closing price of the SVS on the TSXV as at the end of trading on June 1, 2021 (the "Transaction").
- Pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"), the Transaction constitutes a "related party transaction" as the creditor is considered a related party of the Company. The Company is relying on exemptions from the formal valuation and minority approval requirements of MI 61-101 (pursuant to subsections 5.5(a) and 5.7(a)) as the fair market value of the securities distributed to, and the consideration received from, the related party does not exceed 25% of the Company's market capitalization. The Transaction was approved by all the independent directors of the Company.
- All SVS issued in connection with the Transaction will be issued in reliance on certain prospectus exemptions available under securities legislation and will be subject to a four-month statutory hold period. The Transaction remains subject to all necessary regulatory approvals including final acceptance by the TSXV.
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 the 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. Such forward-looking statements include, without limitation, the impacts and outcomes of any collaboration with the Miami University, the outcomes of the Companys development of its proprietary biosynthetic formulation of norbaeocystin, statements with respect to being listed on the OTC Markets, the timing of commencement and termination of the NCIB, the number of SVS the Company that will purchase under the NCIB, and any expected revenues relating to the Company.
In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: the NCIB and the Transaction will be approved by the TSXV; PsyBio will be successful in protecting its intellectual property and filing new patent applications within the next year; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining IND Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio's technology will be safe and effective; 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 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.