Psyched Wellness Announces Key Findings from the 90-Day Oral Toxicity Study on AME-1

Psyched Wellness Announces Key Findings from the 90-Day Oral Toxicity Study on AME-1

Toronto, Ontario–(Newsfile Corp. – February 15, 2022) – 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 the key results from the 90-day oral toxicity preclinical study on its proprietary extract of the Amanita Muscaria mushroom (AME-1), with its contract research organization (CRO) partner.

The study was the third set of a group of thorough assessments on AME-1 conducted to determine the systemic toxicity potential of the Amanita Muscaria extract when administered once daily for 90 consecutive days, and summarizes the NOAEL (No Observed Adverse Event Level).

“This is the final step in the toxicological assessment of AME-1 that will form the foundation for the effective safe dose for human consumption and provides the necessary information for any future clinical studies,” said Brian Tancowny, Scientific Advisor for Psyched Wellness. “With no adverse effect reported over the period, the study results reinforce our earlier findings about AME-1’s safety and allows continued development of our products for human consumption.”

A summary of the key findings in the report are as follows:

  • No adverse clinical signs of toxicity and neither mortality nor morbidity observed in both genders for vehicle and test item treated animals during the study period.
  • No treatment-related adverse effects on body weight and normal body weight gain were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
  • No treatment-related adverse effects on feed consumption were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
  • No treatment-related adverse effects on hematology parameters, coagulation, clinical chemistry, gross necropsy, and organ weights. All parameters studied were found to be normal during the duration of the study period.
  • No observed adverse event level occurred. This significant set of information obtained has resulted in the determination of the NOAEL and thus identified the safe effective dose for human consumption.

Jeffrey Stevens, CEO of the Company, said, “In addition to undertaking the 90-day toxicity study, Psyched has been focused on preparing the Self-Gras dossier which will position the Company to be able to sell products into the U.S. market and generate revenues in the first half of 2022. Our CRO partner was diligent in updating us on preliminary results throughout the study, advising that there were no findings of concern being recorded. We were very pleased that there were no adverse effects found in the toxicity study, and are grateful to our investors for their patience while the report was being finalized.”

Mario’s secret revealed 🍄

Psyched Wellness Provides Update on Anti-Inflammatory Study with the National Research Council of Canada

The iconic red and white spotted mushroom (officially called Amanita Muscaria and unofficially called the Super Mario mushroom) is showing potential to treat arthritis.

Psyched Wellness (PSYC) is working with the National Research Council of Canada (NRC) to study the mushroom’s properties. It doesn’t contain psilocybin, but has a different psychoactive component called muscimol.

Preliminary data suggests that Amantia Muscaria could reduce inflammation in the skin, gut, brain, and lungs. The company believes it has potential to treat chronic inflammatory conditions like arthritis.

Maybe that’s why Mario can jump so high without destroying his joints 😉

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Psyched Wellness Announces Vantage Hemp Co. as Contract Manufacturing Organization Partner to Bring AME-1-derived Products to Market

Psyched Wellness Announces Vantage Hemp Co. as Contract Manufacturing Organization Partner to Bring AME-1-derived Products to Market

Canadian brand leading the emerging functional food category partners with industry-leading extraction and manufacturing partner based in Greeley, Colorado

Toronto, Ontario – January 18, 2022 – 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 Vantage Hemp Co. as the Company’s contract manufacturing organization (“CMO“) partner, facilitating the path to market for Psyched’s AME-1-derived consumer products.

The agreement includes extraction, commercial production and bottling of the products, with the Companies working together to finalize the good manufacturing practices (“GMP“) compliance process and final product formulation through Vantage’s established production capabilities. Psyched has shipped samples of raw material and the desired extract to Vantage’s facilities which will follow the Company’s unique protocols (as outlined in provisional patents submitted last year) to have the first commercial production of AME-1 units ready for sale during the second quarter of 2022. In addition, The Companies plan to develop future products and delivery systems with AME-1 as the base and core ingredient.

“Psyched Wellness is very pleased to partner with Vantage, an established extract manufacturer that meets our high standards of pharmaceutical quality and shares our vision for the future,” said David Shisel, Chief Operating Officer of Psyched Wellness. “Together, we plan to produce and supply the highest quality products to global markets, starting with the United States before scaling distribution internationally. The AME-1-derived supplements that Psyched has been developing for the past two years are natural remedies that will improve the quality of life for many. For the first time in modern history, Psyched Wellness will present a product derived from the Amanita Muscaria mushroom that is safe for human consumption using our proprietary extract, AME-1. Psyched and Vantage both believe in the success of AME-1 as an ingredient and are ensuring that we have the infrastructure and capabilities to scale production to high volumes without sacrificing quality.”

Vantage’s manufacturing facilities and processes are ICH Q7 and WHO GMP-compliant and are managed by an expert team that specializes in medical, pharmaceutical, manufacturing and business operations, creating the highest quality products with precision and scale. In addition, Vantage’s cleanroom for the production of finished products ensures the final products are manufactured in controlled environments that mitigate contamination.

Harvinder Johal, CRO of Vantage, added, “Our partnership with Psyched Wellness ensures that this valuable therapy will be brought to market at an accelerated rate by leveraging Vantage’s science-based and data-driven ethos. We are eager to allow consumers access to this product for the improvement of their health and wellness. Applying our extraction standards to mushroom biomass ensures that the final product meets the same stringent quality standards that we apply to hemp extraction.”

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
Tel: 647-400-8494
Email: jstevens@psyched-wellness.com
Website: http://www.psyched-wellness.com

Christian Santi
Director of Sales
Vantage Hemp Co.
Tel: 720-663-6082
Email: christian@vantagehemp.com
Website: https://vantagehemp.com/

Investor contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
Tel: 347-487-6788
Email: PsychedWellness@kcsa.com

Media contacts:
Brooke Russell
Marigold Marketing & PR
Tel: 877-681-5541
Email: brussell@marigoldpr.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.

About Vantage Hemp Co.:

With large-scale extraction facilities, Colorado-based Vantage Hemp Co. delivers pharmaceutical-grade GMP compliant CBD extracts (including full-spectrum oil, distillate and isolate) that companies can trust. Vantage’s contract manufacturing services offer a broad range of benefits as they operate with integrity and abide by stringent pharmaceutical-production standards to provide quality products to their partners.

Cautionary Statement Regarding Forward-Looking Information

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; Vantage Hemp Co,’s relationship with the Company, including them providing CMO and other services to the Company; the parties anticipated timeline and process for meeting production and commercialization; and the Company becoming a leading North American brand in the emerging functional food category.

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; Vantage Hemp Co. providing CMO and other services to the Company; the parties meeting their anticipated timeline and process for production and commercialization; and the Company becoming a leading North American brand in the emerging functional food category.

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; risk that Vantage Hemp Co.’s will be unable to provide CMO and other services to the Company; risks that the parties will be unable to meet their timeline and/or follow their process for production and commercialization; and risks that the Company will not become a leading North American brand in the emerging functional food category.

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.

Psyched Wellness Announces Path to Market for AME-1-derived Products in the USA

Psyched Wellness Announces Path to Market for AME-1-derived Products in the USA

Toronto, Ontario – December 16, 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 is moving forward with its regulatory strategy to launch its Amanita Muscaria extract (“AME-1“)-derived consumer products in-stores in the United States market in the second quarter of 2022.

To achieve this, the Company is having a self-Generally Recognized As Safe (“GRAS“) dossier reviewed by an external GRAS panel of experts for the AME-1. The self-GRAS review process, which was recently upheld in federal court in the Southern District of New York, permits substances that are self-determined to be GRAS to be exempt from pre-market review by the FDA.

The self-GRAS process will permit AME-1 to be sold in specific foods outlined in the dossier and provide an exemption from pre-market notification as a New Dietary Ingredient (“NDI“) in dietary supplement products. Despite this allowable exemption from NDI notification, Psyched will proceed with plans to notify the FDA with an NDI notification and submit to Health Canada for a Natural Health Product Number (“NHPN“).

As AME-1 is a food supplement, Psyched is able to run parallel paths and sell in multiple food categories and jurisdictions: (i) completing a self-determined GRAS for inclusion of the ingredient in US conventional foods, (ii) submitting an NDI notification to the FDA for use and marketing in US dietary supplements, and (iii) applying to Health Canada for marketing as a natural health product.

“The ruling in late September on the FDA’s GRAS Self-Determination process is significant as it was upheld in the federal court in the Southern District of New York. The self-GRAS and NDI pathways will allow the Company to market AME-1 in conventional foods (Nutrition Facts) outlined in their GRAS, as well as dietary supplements (Supplement Facts), a category of food. These plans, as well as their application for an NHPN, will provide for greater penetration into additional food categories,” said KGK Science Chief Executive Officer, Najla Guthrie.

“While Psyched Wellness would have exemptions from having to file a NDI notification after completing a self-determined GRAS, the Company is going above and beyond their regulatory requirement by also planning to submit an NDI notification to the FDA. These are the actions of a company setting the bar high for food ingredient safety standards,” said KGK Science Chief Regulatory Officer, Corey Hilmas, MD/PhD.

“This is an important and logical step forward as we pursue our strategy to create premium Amanita Muscaria mushroom-derived products and become a leading North American brand in the emerging functional food category,” said Jeff Stevens, Chief Executive Officer of Psyched. “Working closely with KGK Science, we determined that applying for a self-GRAS, in addition to our NDI and NHPN action plans, de-risks and expedites our path to market in the United States.”

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: (347) 487-6788
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

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 executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.

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 executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.

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; risks that the Company will be unable to execute its plan and will not have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; risk that the Company will be unable to complete the GRAS review process upon the terms and timelines as disclosed herein; risks that the Company will be unable to follow or will deviate from its regulatory strategy and be unable to submit some or all of the associated applications as disclosed herein; risk that the Company will be unable to run parallel paths and sell in multiple food categories and jurisdictions; and risks that the Company will not become a leading North American brand in the emerging functional food category.

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.

Psyched Wellness Hires Del Mahabadi as Digital Marketing Consultant to Drive AME-1 Product Launch

Psyched Wellness Hires Del Mahabadi as Digital Marketing Consultant to Drive AME-1 Product Launch

Toronto, Ontario – December 14, 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 hired Del Mahabadi as Digital Marketing Consultant to drive the launch of the Company’s AME-1 products to market next year.

Ms. Mahabadi is a highly successful marketer and leader with a long track record of helping organizations effectively develop and execute marketing strategies, enabling growth. Her specialties lie in using digital marketing to raise a company’s public profile, increase consumer engagement and develop powerful and profitable ways to further connect with consumers. She has led several creative digital marketing strategies over a variety of industries, including cosmetics, government, and arts and culture.

Ms. Mahabadi holds a Bachelor of Science degree from Ryerson University, a Postgraduate Degree in Communications and Digital Marketing, and a Diploma in Data Science. In addition, she runs a nonprofit organization, supported by Google for Nonprofits, the Federal Government of Canada, and Factor Canada. In 2021, Del was a finalist for the Arts and Cultural Leadership award of the Ontario Arts Council.

Psyched Wellness Chief Commercial Officer, Matthew Singh, commented, “Del joining our team is an integral step as we transition to a CPG entity and bring our AME-1 products to market. She has a wealth of experience creating brands that disrupt the status-quo and then evolve to become household names. Del has facilitated the growth of tincture-based products, like Deciem, and we are eager to learn from her knowledge and experience. We are also excited to launch our new website, product pre-sales, and evolved brand strategy, in the coming weeks.”

Ms. Mahabadi added, “Psyched Wellness is driving innovation in the psychedelic mushrooms industry with the aim of developing products that can help with stress relief, relaxation and restful sleeping. I am delighted to join the Psyched Wellness team at such a pivotal time of growth, and look forward to bringing about change with the launch of our AME-1 products next year.”

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: (347) 487-6788
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.

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.

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.

Psyched Wellness to Present at H.C. Wainwright 2nd Annual Psychedelics Conference, 2021

Psyched Wellness to Present at H.C. Wainwright 2nd Annual Psychedelics Conference, 2021

Toronto, Ontario – November 30, 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, today announced that Chief Executive Officer, Jeffrey Stevens, and David Shisel, Chief Operating Officer, will present at H.C. Wainwright’s 2nd Annual Psychedelics Conference on Monday, December 6th, 2021.

A recording of Psyched’s presentation will be available on-demand from Monday, December 6th at 7:00 a.m. Eastern Time, through the following link: https://journey.ct.events/view/954b1eb8-cd02-488e-acfd-910c0869fd6b.

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

In addition, the Psyched management team will be participating in one-on-one meetings throughout the event. To schedule a one-on-one meeting with Psyched’s management team, please contact KCSA Strategic Communications at PsychedWellness@kcsa.com.

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 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 Psyched Wellness Ltd. current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by Psyched at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information, including, without limitation, (i) the accuracy of the Toxicology Assessment, (ii) the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof, and (iii) the uses and potential benefits of Amanita Muscaria. Given these risks, uncertainties, and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Psyched is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Psyched Wellness Ltd. management’s discussion and analysis for the six months ended May 31, 2020 and covering the subsequent period up to July 27, 2020 (“MD&A”), dated July 27, 2020, which is available on Psyched Wellness Ltd. profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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.