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PsyBio Therapeutics Reports First Quarter 2021 Financial Results, Provides Shareholder Update and Announces Intention to Institute Share Buyback Program

CEO, Evan Levine, to Host ‘Revolutionizing Psychedelic Medicine’ Webinar on Wednesday, June 2nd at 1 p.m. ET

PsyBio Therapeutics Corp.(CVE: PSYB)(OTCMKTS: PSYBF), 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:

https://bit.ly/2ROjwVn

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.

To view the original press release in its entirety click here

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