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Psyched Wellness is pioneering research into the health benefits of Amanita Muscaria mushrooms

Snapshot

The company is developing Amanita muscaria-derived water-based extracts (AME-1), teas and capsules designed to help promote stress relief, relaxation, and assist with restful sleeping

Psyched Wellness -

Quick facts: Psyched Wellness

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CSE:PSYC

Price: 0.16 CAD

Market Cap: $12.87 m
  • Research leader for the health benefits of Amanita Muscaria mushrooms
  • Engaged in pre-clinical trials on the company’s proprietary extract AME-1
  • Well funded after recent equity raise

What Psyched Wellness does:

Psyched Wellness Ltd (CSE:PSYC) (OTCQB:PSYCF) (FRA:5U9), formerly Duncan Park Holdings Corporation, is a Canadian health supplement company dedicated to protect, restore and regain a healthier body and mind through the production of products derived from artisanal, medicinal and psychedelic mushrooms. 

The Toronto-based company’s first line of products will be derived from the unique and famous looking psychedelic medicinal mushroom Amanita Muscaria, and its psychoactive compound Muscimol.

Psyched Wellness is targeting the creation of premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. It is in the process of developing a line of Amanita muscaria-derived water-based extracts (AME-1) in teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

The Amanita Muscaria mushroom, which grows wild throughout the temperate and boreal regions of the Northern Hemisphere, is easily recognizable with its red and white cap and has been used in traditional healing practices for centuries, according to the company.

Amanita Muscaria has three main components that activate the nervous system: ibotonic acid, muscimol and muscazone. Isolating muscimol compounds have been shown to treat stress and anxiety, ease muscular pain and promote restorative sleep. 

Psyched Wellness is led by CEO Jeffrey Stevens, the former president and chief operating officer of Datametrex AI Limited (CVE:DM), who has more than 20 years of capital markets experience in addition to structuring multiple M&A transactions and building successful businesses.

How is it doing:

In March 2021, Psyched Wellness announced that it had signed an additional agreement with its contract research organization (CRO) partner, KGK Science, to further study the anti-inflammatory nature of its proprietary Amanita muscaria extract AME-1. 

The aim of the study is to explore the anti-inflammatory properties of AME-1 extract and demonstrate activities that may enhance digestive barrier function and immunity. 

Earlier in the same month, the company said it had submitted a provisional patent application with the US Patent and Trademark Office to cover its unique extraction processes for its AME-1 extract.

Also in March, Psyched Wellness reported “positive” results from its Maximum Tolerated Dosage (MTD) study of AME-1 conducted by KGK Science. The study, which was the first set of thorough toxicology assessments on the company's AME-1 extract, summarized the maximum tolerated dose and LD50 thresholds for AME-1 while clearing the way for the next step of pre-clinical studies involving a 14- and 90-day oral toxicity to further identify a safe, effective dose for human consumption.

And in February, Psyched Wellness provided an update on a study focused on determining the effectiveness of the company's AME-1 extract and the active compound muscimol from the Amanita Muscaria mushroom for potential dual antioxidant and anti-inflammatory properties.

The company noted that an initial set of preclinical tests examining potential allergenicity have been completed and results demonstrate that AME-1 does not have any allergenic properties in an in-vitro cell-based mast cell model, adding that subsequent studies are being conducted to further support these findings, while antioxidant and anti-inflammatory studies are also underway.

Previously, highlights from the toxicology assessment conducted by KGK Sciences had “shown a great potential and a clear path for the company to move forward with the development and scale-up of its unique extract,” according to Psyched Wellness.

The company also reported that it has submitted an application with the United States Patent and Trademark Office (USPTO) to register the trademark ‘AME-1’ in connection with the company's extraction technology.

Psyched Wellness believes that AME-1 will be the base for its future Amanita Muscaria product lines in both the health and wellness and the pharma side, and the company said it will continue to identify novel uses for AME-1, as well it will look to build a patent portfolio around AME-1 for new pharmacologically-optimized psychedelic medicines.

On the financial front, in February Psyched Wellness closed a bought deal private placement for total gross proceeds of C$6.6 million, after issuing 21.3 million units to subscribers at a price of $0.31 per unit.

The company said proceeds from the offering will be used to fully fund pre-clinical trials and continue its scientific research of AME-1 and of its potential benefits for people suffering from serious mental and physical health issues, as well as for general corporate purposes.

And in January Psyched Wellness stock was selected as one of the 17 companies in the US and Canada to be included in the first psychedelic exchange-traded fund, managed by Horizons ETF Management, which began trading on January 26 under the ticker ‘PSYK’ on the NEO Exchange.

What the analyst says:

Proactive Research analyst Ed Stacey published an update on Psyched Wellness on April 14, saying the company is developing a range of dietary supplements, starting with a tincture, using a mushroom called Amanita Muscaria, which has psychedelic properties but has never been a scheduled substance in the US or Canada. 

“The company has plans in place for a rapid ramp-up of manufacturing via a contract manufacturing organisation, and distribution through bricks and mortar retailers and e-commerce channels. We expect first commercial revenues in 4Q 2021 and scaling up during 2022,” the analyst wrote.  

Stacey noted that Amanita Muscaria has been used since ancient times for medicinal or spiritual purposes in many different cultures, and formed the basis of the ritual beverage soma — ‘the drink of the gods’.

The company plans to use its mushroom-based health supplements to promote a healthier body and mind.

The Proactive Research analyst pointed out that the functional mushrooms market is a large and growing segment in consumer health, currently running at around US$30 billion per year globally.

And while psychedelic mushrooms are believed to offer physical and mental health benefits when consumed at low doses, Stacey cautioned there are significant obstacles, as varieties such as psilocybe mushrooms (magic mushrooms) are illegal in most jurisdictions.

“The products will require regulatory approval only as novel foods, rather than a more time-consuming pharmaceutical trial process that would be required if Psyched Wellness wanted to market Amanita Muscaria products as medicines rather than wellness products,” Stacey concluded.

Inflection points:

  • Completing pre-clinical trials and rodent testing for safety and efficacy of AME-1
  • Establishing sales channels for its products in Canada, the US, and Europe
  • US Food and Drug Administration and Health Canada approval to sell AME-1 as a health supplement

What the boss says:

Commenting on the company’s Muscimol antioxidant and anti-inflammatory study, Psyched Wellness CEO Jeffrey Stevens said in a statement: “The research from these studies supports what we already believe-that this special compound will have therapeutic benefits.”  

He added: “It is our job to continue to work hard to uncover AME-1's potential, and our research and development team will continue to examine all potential ways that Amanita Muscaria can have positive impacts on health and wellness.”

Contact Sean at sean@proactiveinvestors.com

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Psyched Wellness begins clinical sleep study on humans, included in...

Psyched Wellness (CSE:PSYC, FRA:5U9, OTCQB:PSYCF) Ltd CEO Jeff Stevens tells Proactive it has initiated the first steps towards a clinical sleep study for a structure/function claim for its proprietary extract (AME-1) from Amanita Muscaria mushrooms. The company said the aim of the study is...

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