Posted on

Psyched Wellness Announces Completion of Its 90 Day Oral Toxicity Study

Psyched Wellness Announces Completion of Its 90 Day Oral Toxicity Study

Toronto, Ontario – December 6, 2021 – Psyched Wellness Ltd. (CSE: PSYC)(OTCQB: PSYCF)(FSE: 5U9) (the “Company” or “Psyched“) a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that further to the please release dated June 28, 2021, the 90-day oral toxicity study has been completed.

KGK, the Company’s CRO partner, is now completing the 28-day recovery period, after which a tissue histopathology examination and final report will follow.

A full toxicology report of the 90-day oral repeat-dose study with AME-1 and final histopathology report is expected by mid-January 2022.

“The completion of the 90-day oral toxicity study is a major milestone for Psyched as it provides critical scientific data for the determination of safe dosage levels of AME-1, from which all of our consumer products will be derived as we prepare to launch them to market next year,” said Jeffrey Stevens, CEO of Psyched. “Although we are waiting for the final report, we are pleased to share that there was no mortality or morbidity of any of the test rodents during the study and we look forward to providing the full toxicology and histopathology reports early next year.”

The study examined the effects of Amanita Muscaria on rodents and involved a repeated dose 90-day oral toxicity study of AME-1. The new data will provide information on the major toxic effects, indicate target organs and the possibility of accumulation of test chemical, and can provide an estimate of a no-observed-adverse-effect level (NOAEL) of exposure which can be used in selecting dose levels for chronic studies and for establishing safety criteria for human exposure.

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: (647) 400-8494
e: jstevens@psyched-wellness.com
Website: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (978) 505-2478
e: PsychedWellness@kcsa.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Statement Regarding Forward-Looking Information and Statements

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the uses and potential benefits of Amanita Muscaria; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; the continued growth of the Company; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the risk that there is no potential benefit of Amanita Muscaria consumption; the risk the Company will be unable to develop its products; the inability of the Company to complete their studies and/or reports on the intended timelines; the inability of the Company to generate reliable or positive reports therefrom; and the risk that the Company will not benefit from the studies and/or reports.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

Posted on

Psyched Wellness Presents AME-1 to Health Canada in Pre-Submission Meeting

Psyched Wellness Presents AME-1 to Health Canada in Pre-Submission Meeting

Toronto, Ontario – December 1, 2021 – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that on November 30, 2021, representatives from the Company and KGK Science, the Company’s contract research organization (CRO), presented AME-1, Psyched’s proprietary extract of the Amanita Muscaria mushroom, AME-1, to representatives of Health Canada in a pre-submission meeting.

This follows Health Canada’s approval announced on November 3, 2021 to add Amanita Muscaria mushroom to the Natural Health Products Ingredients Database (NHPID) of Canada.

“Yesterday’s pre-submission meeting was the next important step in positioning the Company to be able to file an application with Health Canada for AME-1 as a Natural Health Product in 2022,” said Jeff Stevens, CEO of Psyched Wellness. “The meeting was very encouraging, and we look forward to incorporating Health Canada’s comments and suggestions into our plans to bring our Amanita-based CPG products to market next year.”

The purpose of a pre-submission meeting is to discuss the evidence required in support of a Class III Product License Application (PLA) or to clarify the type of applications required. Such meetings will:

  • familiarize assessment staff with the proposed application prior to its arrival and provide a forum to discuss the evidence in order to facilitate its assessment;
  • establish which studies or scientific evidence the applicant is relying on to support the safety and/or efficacy of the NHP and discuss the adequacy and appropriateness of controls;
  • provide an opportunity for the applicant to discuss details of the application with Natural and Non-prescription Health Products Directorate (NNHPD) and obtain feedback regarding any areas of concern based on current experience and regulatory requirements; and
  • provide NNHPD an opportunity to re-align resources, if necessary, to accommodate the arrival of the application.

Pre-submission meetings do not entail a full assessment by NNHPD of the evidence presented and, as such, the outcome does not constitute a regulatory decision by NNHPD, nor will a regulatory decision be issued.

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: (647) 400-8494
e: jstevens@psyched-wellness.com
Website: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (978) 505-2478
e: PsychedWellness@kcsa.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Statement Regarding Forward Looking Information and Statements

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward- looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and (ii) the uses and potential benefits of Amanita Muscaria.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the continued growth of the Company.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and the risk that there is no potential benefit of Amanita Muscaria consumption.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

Posted on

Psyched Wellness Appoints Chief Commercial Officer to Lead Sales and Marketing of AME-1 and Launch CPG Products

Psyched Wellness Appoints Chief Commercial Officer to Lead Sales and Marketing of AME-1 and Launch CPG Products

Toronto, Ontario – November 23, 2021 – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“) a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that it has appointed Matthew Singh as Chief Commercial Officer. Mr. Singh will drive the Company’s development into a full-scale packaged goods provider as it prepares to launch its Amanita Muscaria (AME-1)-derived consumer products in 2022.

“I’m thrilled at the opportunity to level-up our executive team and organization as we transition from an R&D-focused start-up to a world-class CPG company,” said Jeffrey Stevens, CEO of the Company. “Matt joining Psyched at this time demonstrates his confidence in the market opportunity of our proprietary extract of the Amanita Muscaria mushroom as a new entrant into the health and wellness category. Matt has already developed a strong sales and branding strategy since he started consulting with Psyched in June and joining us full-time in a leadership role shows the concentration we are putting into bringing our products to market next year.”

Mr. Singh has an extensive track record of success launching brands, products, and corporate strategy within the multibillion-dollar beverage and pharmaceutical industries in Canada and internationally. Accustomed to driving revenue into the hundreds of millions, he was previously the head of VPX Pharmaceuticals’ numerous CPG properties, in Canada and East Asia securing immediate profitability with each Sports Nutrition, Energy Drink, Cannabis, and Alcoholic good VPX added to their portfolio. Prior to VPX, Mr. Singh spent almost a decade at Red Bull Canada, where he ran the company’s Business Development department, and over seven years with Coca Cola. In addition, he is an integral contributor to multiple start-up endeavors as a consultant, board member, and advisor within the health, wellness, and digital intelligence verticals.

Mr. Singh commented, “It was an easy decision to join the team at Psyched full-time. We have developed a truly phenomenal product and look forward to multiple big announcements leading up to a market launch, in 2022. I have been fortunate to work with industry leaders and market disruptors in the extremely competitive beverage and pharmaceutical landscapes throughout my career, and the CPG potential already developed by the team at Psyched has me more excited than anything I have witnessed thus far. We believe this product will have a sustainable commercial and societal impact, starting in North America and then scaling throughout the globe, and I am proud to be a part of the journey with Psyched Wellness. My thanks go to Jeff, David, and the Board for adding me to an already stellar team.”

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: 647-400-8494
e: jstevens@psyched-wellness.com
w: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (978) 505-2478
e: PsychedWellness@kcsa.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Note Regarding Forward-looking Information

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. Forward-looking information includes, but is not limited to, statements with respect to Mr. Singh’s beliefs that the product will have a sustainable commercial and societal impact in North America and the world, Mr. Singh’s beliefs that Amanita will change the world and have the effects it is expected to have on stress relief, relaxation, and sleeping, and the Company’s operational plans including timelines relating to its application with the FDA for a New Dietary Ingredient (NDI) and Health Canada for a Natural Health Product Number (NHPN) in December 2021, and the completion of the pre-clinical trials, and marketing products in the first half of 2022. Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved”. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance, or achievements of the Company, as the case may be, to be materially different from those expressed or implied by such forward-looking information. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended, including the Company’s ability to receive the necessary raw materials needed to complete the research and market the products which further depends on the Company receiving Amanita muscaria mushrooms of the necessary quality and potency, the Company having the resources to complete the research and prepare and file the applications for the NDI and NHPN, and the Company receiving an NDI and NHPN by December, 2021, and the products having the expected impact on stress relief, relaxation, and sleeping.

There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company does not undertake to update any forward-looking information, except in accordance with applicable securities laws.

Posted on

Psyched Wellness Announces That the Amanita Muscaria Mushroom Has Been Successfully Added to the Natural Health Products Ingredients Database (NHPID) of Canada

Psyched Wellness Announces That the Amanita Muscaria Mushroom Has Been Successfully Added to the Natural Health Products Ingredients Database (NHPID) of Canada

Toronto, Ontario – November 3, 2021 – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that Health Canada has approved the Company’s submission to have the Amanita Muscaria mushroom added to The Natural Health Products Ingredients Database (NHPID) of Canada.

Following Psyched’s extensive scientific work in testing and data-gathering on the Amanita Muscaria mushroom and its unique extract – AME-1, the Company had submitted the request to Health Canada to add the Amanita Muscaria mushroom (Fly Agaric) to NHPID as a medicinal organism.

Health Canada has approved the request and classified the Amanita Muscaria mushroom as a Natural Health Product under Schedule 1, Item 1 (a fungus) of the Natural Health Products Regulations. To read more about the classification, please visit this link:

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReq.do?id=18056&lang=eng

Jeff Stevens, CEO of Psyched Wellness said, “The addition of Amanita Muscaria to the NHPID is a significant achievement and is the result of extensive research that Psyched has undertaken to demonstrate its natural medicinal properties. This milestone moves us closer to being able to bring our Amanita-based CPG products to market which we are developing to promote stress relief, relaxation and assist with restful sleeping through the natural calming powers of AME-1.”

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: (647) 400-8494
e: jstevens@psyched-wellness.com
Website: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (978) 505-2478
e: PsychedWellness@kcsa.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Statement Regarding Forward-Looking Information and Statements

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and (ii) the uses and potential benefits of Amanita Muscaria.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the continued growth of the Company.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and the risk that there is no potential benefit of Amanita Muscaria consumption.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.