PsyBio Therapeutics to Seek Approval of Proposed Share Consolidation at Annual and Special Meeting of Shareholders

PsyBio Therapeutics to Seek Approval of Proposed Share Consolidation at Annual and Special Meeting of Shareholders

OXFORD, Ohio and DENVER, June 27, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), announces that it will be hosting its annual general and special meeting of shareholders (the “Meeting“) virtually at 11:00 am Eastern Time on Thursday, August 11, 2022, as further detailed in proxy materials being distributed to shareholders, which will be available under the Company’s profile on SEDAR at www.sedar.com.

At the Meeting, the Company intends to seek the approval of its shareholders to, among other things, potentially consolidate all of its issued and outstanding subordinate voting shares (“SVS“) and multiple voting shares (“MVS” and, together with the SVS, collectively, the “Shares“) on the basis of a consolidation ratio to be approved by the Company’s board of directors (the “Board“) in accordance with the Company’s articles (the “Consolidation Ratio“), provided that the Consolidation Ratio will be no greater than one post-consolidation Share for every 70 pre-consolidation Shares (the “Consolidation“). The Company is not contemplating any name change in connection with the Consolidation at this time. The Consolidation remains subject to the approval of the Company’s shareholders and acceptance by the TSX Venture Exchange (the “TSXV“).

If the Consolidation Resolution is approved by shareholders at the Meeting, subject to acceptance of the Consolidation by the TSXV, the Board will have discretion to determine when to implement the Consolidation, if at all, and shall determine the Consolidation Ratio at that time. The actual timing for implementation of the Consolidation, if any, will be determined by the Board based upon its evaluation as to when such action would be most advantageous to the Company. If the Board decides to move forward with the Consolidation, provided the Consolidation is approved by shareholders at the Meeting, the Company will disseminate a news release disclosing further details relating to the Consolidation, including the final Consolidation Ratio and the proposed date on which the Consolidation will be effected.

Effect of Consolidation

If the Consolidation is approved and implemented, the principal effect will be to proportionately decrease the numbers of issued and outstanding Shares, based on the Consolidation Ratio selected by the Board and within the range approved by shareholders.

There are currently 61,960,306 SVS and 49,378.706 MVS issued and outstanding. Assuming the maximum Consolidation Ratio of 70 pre-consolidation Shares for every one (1) post-consolidation Share, based on the number of Shares currently outstanding, for illustrative purposes only, the number of Shares issued and outstanding immediately following the completion of the Consolidation would equal approximately 885,147 SVS and 705.411 MVS.

Any fractional post-Consolidation SVS will be will be rounded down to the nearest whole number, and any fractional post-Consolidation MVS will be will be rounded down to the nearest three decimal points. Any such rounded fractional post-Consolidation Shares will be deemed to have been tendered by its registered owner to the Company for cancellation for no additional consideration.

Reasons for Consolidation

The Board is seeking authority to implement the Consolidation in order to reduce the number of Shares issued and outstanding, because the Board believes that: (i) it is desirable for its SVS to trade at a higher price per share, and the Consolidation could potentially result in such an increase; and (ii) an increased trading price could potentially broaden the pool of investors that may consider investing or may be able to invest in the Company, potentially increasing the trading volume and liquidity of the SVS. The Board anticipates that the Consolidation may result in certain additional ancillary benefits as well, which may not be known at this time. There can be no assurance that the Consolidation will result in any increase in the trading price of the SVS or improved trading volume and liquidity, and if such results occur there can be no assurance that this will be sustained. 

The Board believes that the proposed range of Consolidation Ratios will provide it with the flexibility to implement the Consolidation in a manner designed to maximize the anticipated benefits to the Company since it is not possible to predict market conditions at the time the Consolidation may be implemented. In setting the Consolidation Ratio within the aforementioned range of ratios to implement, if any, following the receipt of shareholder approval, the Board may consider, among other things, factors such as: (i) the historical trading prices and trading volume of the SVS; (ii) the then prevailing trading price and trading volume of the SVS; (iii) the anticipated impact of the Consolidation on the trading market(s) for the SVS; (iv) the number of SVS that may be issued pursuant to outstanding securities exercisable or exchangeable for, or convertible into, SVS, and pursuant to the exercise of the issued SVS purchase warrants; (v) the overall reduction of the Company’s administrative costs; and (vi) prevailing general market and economic conditions.

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: the Meeting; the Consolidation; the Consolidation Ratio; the Company’s expectation that the Company’s name will not be changed; treatment of fractional Shares in connection with the Consolidation; the effect of the Consolidation on the issued and outstanding Shares; the anticipated number of Shares outstanding post-Consolidation; the reasons for and potential anticipated benefits of the Consolidation, including increased trading price, volume and liquidity in respect of the SVS; that an increased trading price for the SVS could potentially broaden the pool of investors that may consider investing or may be able to invest in the Company; anticipated ancillary benefits to the Consolidation; 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: the Meeting will be held as scheduled; the Consolidation will be approved by shareholders and accepted by the TSXV; the Consolidation will result in certain anticipated benefits to the Company and its shareholders; it is desirable for the SVS to trade at a higher price per share; the Consolidation could potentially result in such an increase which could potentially broaden the pool of investors that may consider investing or may be able to invest in the Company, potentially increasing the trading volume and liquidity of the SVS; and the Consolidation may have certain additional ancillary benefits. 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 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: that the Meeting could be rescheduled, adjourned or otherwise modified; that the post-Consolidation trading price of the SVS may be impacted by several factors in addition to the Consolidation, including the Company’s financial and operational results, its available capital and resources, the state of the market for the Shares at the time, general economic, geopolitical, market and industry conditions, the market perception of the Company’s business and other factors and contingencies which are unrelated to the number of Shares outstanding; that the Consolidation could not be approved by shareholders and/or by the TSXV, or that even if such approvals are obtained, the Board could determine in its discretion not to proceed with the Consolidation as planned, if at all; that the number of Shares outstanding on the record date for the Consolidation, if implemented, will be different than set out in this news release; that the Company may otherwise alter its authorized share structure or share provisions, including as set out in the proxy materials for the Meeting; 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 United Statement Food and Drug Administration (“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.

SOURCE PsyBio Therapeutics Corp.

For further information: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Investor Enquiries: Valter Pinto and Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com

PsyBio Therapeutics Develops Commercial Purification Process for Second Generation Psycho-Targeted Compound

PsyBio Therapeutics Develops Commercial Purification Process for Second Generation Psycho-Targeted Compound

PsyBio Therapeutics Further Expands Scalable Manufacturing Process Development

OXFORD, Ohio and COCONUT CREEK, Fla., May 16, 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 reported that it has achieved a commercially scalable purification method for one of its second generation compounds. This manufacturing process achievement is expected to enable the commercial scale purification of bioreactor produced products utilizing state of the art manufacturing methodology to further expand PsyBio’s portfolio of compounds that can be more readily and rapidly developed than competitive methods. This purification process methodology is a necessary component for the Chemistry, Manufacturing and Controls section (“CMC”) for this second-generation candidates Investigational New Drug (“IND”) application with the US Food and Drug Administration (“FDA”).

“Developing adequate and scalable methodology for the purification of pipeline compounds will allow PsyBio to enable bench scale technology to be adapted to modern biotechnological production efficiency. This technology is necessary to produce reliable and predictable purity which allows more rapid development of large scale lots of material,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “This is expected to facilitate effective in vitro and in vivo testing, moving towards additional clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health.”

PsyBio retains the global, exclusive, and perpetual right to license a platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale. Commercial purification process development furthers the ability to manufacture compounds with predictable and reproducible purity.

“PsyBio continues to make significant progress in the manufacturing arena, developing effective and scalable techniques to enhance the ability to produce an ever-growing number of psycho-targeted therapeutic candidates in a rapid and highly cost-efficient manner,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The development of this type of manufacturing processes improves PsyBio’s capability to develop and rapidly manufacture novel therapeutic agents. PsyBio remains one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds as most of the landscape appears to rely on third party providers.”

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: the impact of this manufacturing process achievement on commercial scale purification; the impact of this manufacturing process achievement on the CMC section of PsyBio’s IND application with the FDA; PsyBio’s ability to develop compounds more readily and rapidly than competitive methods; PsyBio’s plans for filing IND applications with the FDA; the impact of this new manufacturing on potential in vitro and in vivo testing; PsyBio’s plans to move towards additional clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health; PsyBio’s ability to develop novel therapeutic agents; PsyBio’s ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio’s ability to launch 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: this manufacturing process will enable commercial scale purification of bioreactor produced products; this manufacturing process will have a positive impact on potential in vitro and in vivo testing; this manufacturing process will have a positive impact on progress toward the filing of IND applications with the FDA; PsyBio will be successful in protecting its intellectual property; 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 will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; 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.

PsyBio Therapeutics Initiates Blood-Brain Barrier Permeability Testing for Pipeline Compounds to Enhance Portfolio Development

PsyBio Therapeutics Initiates Blood-Brain Barrier Permeability Testing for Pipeline Compounds to Enhance Portfolio Development

PsyBio Therapeutics Further Expands Testing of Portfolio Compounds

OXFORD, Ohio and COCONUT CREEK, Fla., May 6, 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 reported that it has expanded its pre-clinical pipeline activities by initiating blood-brain barrier permeability testing. This additional testing procedure is expected to provide a comprehensive, state of the art research methodology with which PsyBio’s ever expanding portfolio of compounds can be more readily and rapidly developed. Favorable results from this type of testing are anticipated to expediate compound selection and progress toward the filing of Investigational New Drug (“IND”) applications with the US Food and Drug Administration (“FDA”).

“Establishing this type of testing is critically important for PsyBio to allow candidate selection to proceed more rapidly,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “We expect that this will allow us to effectively screen and select compounds that are active both in vitro and in vivo to more efficiently produce psycho-targeted therapeutics intended to potentially improve mental and neurological health.”

PsyBio retains the global, exclusive, and perpetual right to license platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale. This type of permeability testing is expected to improve the selection ability for compounds able to cross the blood-brain barrier and ultimately produce a brain-based effect.

“We continue to apply and utilize state-of-the-art research methodology to further our ability to produce a variety of psycho-targeted therapeutic candidates as one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The initiation of this type of pre-clinical laboratory testing is expected to improve PsyBio’s ability to develop novel therapeutic agents.”

The Company is not proceeding with its previously announced proposed acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as described in the Company’s press release dated March 15, 2022.

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 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; PsyBio’s plans for filing IND applications with the FDA; PsyBio’s ability to develop novel therapeutic agents; PsyBio’s ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio’s ability to launch 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: 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 protecting its intellectual property; 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 will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; 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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PsyBio Therapeutics Begins Filing Global Provisional Patent Conversion Applications to Further Strengthen Biosynthetic Patent Portfolio

PsyBio Therapeutics Begins Filing Global Provisional Patent Conversion Applications to Further Strengthen Biosynthetic Patent Portfolio

PsyBio Therapeutics further extends and expands intellectual property protection

OXFORD, Ohio and COCONUT CREEK, Fla., April 27, 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 is announcing that it has 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. This continued collaboration with Miami University is anticipated to expedite progress toward the filing of an Investigational New Drug (“IND“) application with the United States Food and Drug Administration (“FDA“).

“We remain focused on the development of psycho-targeted therapeutic candidates as one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “Intellectual property protection is crucial for our current and future investors and partners, and we continue to be committed to the ongoing development and submission of patent applications and conversions.”

PsyBio acquired the global, exclusive, and perpetual rights to license the platform technology developed at Miami University in Oxford, Ohio enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria. Ongoing patent coverage extension such as this submission further extends and expands that intellectual property protection.

“Solidifying these provisional patents and protecting our intellectual property is vital for the development of PsyBio, which is in the process of pre-manufacturing and production optimization,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The submission of the additional data regarding the process and production of tryptamines and related compounds is an important step in our growth objectives.”

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an 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. 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: the ability of PsyBio to convert existing provisional patents to full patents; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to build and protect 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; 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: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug 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-19general business, economic, competitive, political and social uncertainties; and the risk factors set out in the Company’s management discussion and analysis for the period ended December 31, 2021 and the Company’s annual information form dated March 2, 2022, which are available under the Company’s profile on www.sedar.com. 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.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2022/27/c0808.html

PsyBio Therapeutics Initiates Clinical Trial Site Selection Process

PsyBio Therapeutics Initiates Clinical Trial Site Selection Process

PsyBio Therapeutics is developing a network of highly qualified, local principal investigators to recruit and conduct upcoming clinical trials

OXFORD, Ohio and COCONUT CREEK, Fla., April 13, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an 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 is announcing that it is initiating the process of recruiting, evaluating and selecting highly qualified investigators for upcoming clinical trials.

“The process of site selection is critically important to the success of clinical investigations,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “My experience running thousands of studies as a former clinical trial investigator and trial site operator will allow PsyBio to develop partnerships with the clinical trial site investigators and work in collaboration with qualified sites to ensure the highest quality data collection and the shortest timelines for clinical studies. While we have started to discuss potential participation in upcoming trials, there is still opportunity for other investigators to participate should a qualified investigator or site seek further information.”

PsyBio is currently in the process of drafting its second pre-IND application in anticipation of seeking investigational new drug (“IND“) approval from the United States Food and Drug Administration (“FDA“) for upcoming clinical trials.  Once submitted and approved by the appropriate regulatory authorities, including the FDA, clinical investigators will be selected and trained to conduct clinical investigations, which will help facilitate rapid trial initiation and completion. 

“The ability to launch clinical trials with our readily manufacturable and scalable psycho-targeted therapeutic candidates, once regulatorily approved, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds from bench to bedside,” stated Evan Levine, PsyBio’s Chief Executive Officer. “Collaborating with committed and talented local investigators and using their extensive content knowledge will be invaluable to PsyBio as clinical trials are begun, the data analyzed, and results reported.”About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an 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. 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 and ability to recruit clinical investigators for upcoming clinical trials; PsyBio’s ability to launch clinical trials; PsyBio’s plans and ability to complete its clinical site selection process; PsyBio’s plans to submit a second pre-IND application to the FDA; PsyBio’s ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio’s ability to build its intellectual property portfolio of novel drug candidates; 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: 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; 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 obtaining Investigational New Drug 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; general business, economic, competitive, political and social uncertainties; and the risk factors set out in the Company’s management discussion and analysis for the period ended December 31, 2021 and the Company’s annual information form dated March 2, 2022, which are available under the Company’s profile on www.sedar.com. 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.

For further information: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Valter Pinto or Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com

PsyBio Therapeutics to Participate in the 2022 Maxim Group Virtual Growth Conference on March 28-30, 2022

PsyBio Therapeutics to Participate in the 2022 Maxim Group Virtual Growth Conference on March 28-30, 2022

PsyBio Therapeutics to Participate in the 2022 Maxim Group Virtual Growth Conference on March 28-30, 2022

OXFORD, Ohio and COCONUT CREEK, Fla., March 23, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company focusing on discovering developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that Evan Levine, Chief Executive Officer and Chairman, will participate in the 2022 Maxim Group Virtual Growth Conference on March 28-30, 2022.

PsyBio’s presentation will be available to view on demand beginning at 9:00 a.m. ET on Monday, March 28th. To attend, please register here. To listen to the presentation, please click here to access the webcast.

To schedule a meeting with the PsyBio management team, please contact KCSA Strategic Communications by emailing PsyBio@kcsa.com.

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. 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 activities are 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 psycho-targeted 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.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“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 (“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.

PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa

OXFORD, Ohio and COCONUT CREEK, Fla., March 15, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an 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 announces that it has entered into a definitive agreement (the “Agreement“) to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. (“Everest“), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the “Acquisition“). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.

PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio’s abilities which encompass fully translational capabilities in its current scientific  laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.

“Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The next step is for PsyBio to collaborate with Everest’s current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions.”

Upon completion of the Acquisition, PsyBio will acquire Everest’s active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.

“The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes.”

The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the “SVS“), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange (“TSXV“).

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. 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 activities are 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 psycho-targeted 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: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; 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; 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: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug 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 favorable; 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 U.S. Food and Drug Administration (“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.

SOURCE PsyBio Therapeutics Corp.

For further information: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Investor Enquiries: Valter Pinto or Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com

PsyBio Therapeutics Successfully Completes First Pre-IND Meeting with the United States Food and Drug Administration

PsyBio Therapeutics Successfully Completes First Pre-IND Meeting with the United States Food and Drug Administration

PsyBio is committed to innovate, develop, and optimize technology related to its ever growing psycho-targeted portfolio through formal regulatory pathways

Based on feedback received, PsyBio intends to request its initial compound-specific pre-IND meeting

OXFORD, Ohio and COCONUT CREEK, Fla. , Dec. 7, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (” PsyBio ” or the ” Company “), an intellectual property driven biotechnology company focused upon discovery and development of new, bespoke,  psycho-targeted therapeutics to potentially improve mental and neurological health, today announced the successful completion of its initial pre-Investigational New Drug (” IND “) application meeting with the United States Food and Drug Administration (” FDA “) as part of the regulatory submission process.

PsyBio Therapeutics Corp. logo (CNW Group/PsyBio Therapeutics Corp.)

“PsyBio was created to develop novel therapeutic candidates with the goal to help improve human health,” stated Michael Spigarelli , MD, PhD, MBA, PsyBio’s Chief Medical Officer. “To achieve this goal, regulatory approval for any potential therapeutic candidate is absolutely necessary to bring that product to the patients who may benefit. As such, it is critically important to have open discussions, such as this meeting, with regulatory officials to most efficiently and effectively follow all requirements and guidance to facilitate future approvals.”

The focus of this pre-IND meeting was to discuss potential indications, manufacturing strategy, and obtain regulatory guidance as PsyBio guides its technology forward towards regulatory approval. The responses received from the FDA to these initial set of questions were constructive and no changes were proposed with respect to PsyBio’s approach.  Based upon this initial discussion, PsyBio intends to submit compound specific pre-IND meeting requests to define manufacturing and clinical trial parameters.

“This initial pre-IND meeting marks our formal entry into the regulatory process, which is paramount and of foremost importance to PsyBio as part of our commitment to being a leader in developing psycho-targeted therapeutic candidates,” stated Evan Levine , PsyBio’s Chief Executive Officer. “The FDA has provided invaluable guidance which the Company plans to heed and implement during the development period.  We look forward to collaborating with the FDA and other regulatory agencies to demonstrate our potential therapeutic candidates are safe and effective for their proposed indications.”

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: PsyBio’s plans to submit compound specific pre-IND meeting requests to the FDA to define manufacturing and clinical trial parameters; 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 and protect its intellectual property portfolio of novel drug candidates; 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: 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 IND Applications with the 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.

SOURCE PsyBio Therapeutics Corp.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/December2021/07/c5455.html

PsyBio Therapeutics Sponsors 16 Collaborative Research Abstract Presentations at Two Scientific Conferences

PsyBio Therapeutics Sponsors 16 Collaborative Research Abstract Presentations at Two Scientific Conferences

OXFORD, Ohio and COCONUT CREEK, Fla. , Dec. 2, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (” PsyBio ” or the ” Company “), an intellectual property driven biotechnology company focused on discovery and development of novel, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced, as a result of its sponsored research agreements, sixteen abstracts were submitted for review, accepted through a peer-reviewed process and presented at two scientific conferences as part of its ongoing commitment to share relevant scientific progress and intellectual property portfolio development.

“These recent scientific presentations serve to further expand our contribution to improve mental and neurological health and demonstrates PsyBio’s commitment to being a leader in developing psycho-targeted therapeutic candidates,” stated Evan Levine , PsyBio’s Chief Executive Officer. “Our approach towards collaborative research remains a critical part of our goal.”

These sixteen abstracts cover a wide variety of topics including: biosynthetic pathway and transcriptional methodologic development; evaluation; screening and optimization of systems and organisms; increasing bioproduction yields of natural and non-natural products, as well as the evaluation of impulsivity, motivational, psychiatric, and psychoactive effects of PsyBio’s portfolio of compounds.

“PsyBio remains committed to advancing scientific knowledge and dissemination of results while ensuring intellectual property protection,” stated Michael Spigarelli , MD, PhD, MBA, PsyBio’s Chief Medical Officer. “We are proud of the joint efforts between PsyBio and our sponsored research collaborators that made the sixteen presentations from process development, through biosynthesis and to neurobehavioral testing possible. We will continue to collect data and advance the clinical and scientific knowledge base to be able to help improve mental and neurological health.”

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 and protect 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; 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: 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 IND 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.

SOURCE PsyBio Therapeutics Corp.

Cision View original content: http://www.newswire.ca/en/releases/archive/December2021/02/c4851.html

PsyBio Therapeutics to Present at the H.C. Wainwright 2nd Annual Psychedelics Conference

PsyBio Therapeutics to Present at the H.C. Wainwright 2nd Annual Psychedelics Conference

OXFORD, Ohio and COCONUT CREEK, Fla. Dec. 1, 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 Evan Levine , Chief Executive Officer and Chairman, will present at the H.C. Wainwright 2 nd Annual Psychedelics Conference.

Date:

Monday, December 6, 2021

Time:

On-demand beginning at 7:00 a.m. Eastern Time

Link:

https://journey.ct.events/view/013634f9-6376-4da3-b946-3ecb38454d3f

A recording of the presentation will be accessible on PsyBio’s website via the above link for 90 days.

The PsyBio management team will be available for one-on-one meetings throughout the conference. To schedule a meeting, please contact your H.C. Wainwright representative or KCSA Strategic Communications by emailing PsyBio@kcsa.com .

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.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (” 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 (” 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.

Cision View original content: http://www.newswire.ca/en/releases/archive/December2021/01/c9248.html