01:05:44 EDT Fri 10 Oct 2025
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Psyched Wellness Ltd
Symbol PSYC
Shares Issued 288,816,834
Close 2025-10-09 C$ 0.02
Market Cap C$ 5,776,337
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Psyched downplays FDA's safety comments on AME-1

2025-10-09 17:08 ET - News Release

Mr. Jeffrey Stevens reports

PSYCHED WELLNESS PROVIDES COMPREHENSIVE INVESTOR UPDATE

Psyched Wellness Ltd. has provided a corporate update to its investors.

Product development and launches

Santa -- dietary supplement shot

Following the initial pilot run announced on April 10, 2025, the company has made significant progress on its new dietary supplement shot, Santa.

On Sept. 15, 2025, the company completed an initial production run in preparation for a soft launch on Oct. 1, 2025. A second production run is scheduled for mid-October to ensure adequate inventory for the holiday season.

Scientific studies

On March 14, 2025, the company initiated a genotoxicity study on its proprietary extract, AME-1. The study includes the AMES test, in vitro TK-MLA assay and the micronucleus assay. Progress to date has been promising, and further updates will be shared as results become available.

Additionally, the company engaged a third party laboratory to conduct a six-month accelerated stability study on AME-1. The goal was to evaluate the potential extension of product shelf life beyond the current 12-month period. Results confirm that AME-1 maintains muscimol content up to 18 months and show no microbial growth under accelerated conditions. Accordingly, Calm will now carry an 18-month shelf life.

Patents

Psyched Wellness is pleased to announce that the company submitted a "scaled-up extraction process" application in the USPTO on Aug. 18, 2025, as United States application No. 19/157,676.

The application is now pending in the U.S. and Canada.

Regulatory update

In July, 2025, the company voluntarily submitted a new dietary ingredient notification (NDIN) to the FDA for AME-1, its proprietary extract of Amanita muscaria. Though AME-1 is only derived from Amanita muscaria, the filing included over 100 years of documented food use of Amanita muscaria in a form that has not been altered along with voluntary toxicology and safety studies of AME-1 conducted by the company. While the FDA responded in September, 2025, that the specific data included in the filing by the company did not demonstrate that AME-1 "will reasonably be expected to be safe" the company notes that under the Federal Food, Drug, and Cosmetic Act (FFDCA), the purpose of an NDIN requirement is only to notify the FDA, and the submission does not require FDA concurrence or a favourable review in order for the company to sell its products. Moreover, under the FFDCA the burden rests on FDA to prove a dietary ingredient is unsafe. The company remains confident in AME-1's safety based on Amanita muscaria's historical use and the company's safety studies, continues to view itself as fully compliant with FFDCA, and emphasizes its commitment to transparency and regulatory compliance as it brings additional AME-1 products to market.

Psyched Wellness will be growing its route-to-market partnerships, throughout the nation.

About Psyched Wellness Ltd.

Psyched Wellness is a Canadian-based health supplements company dedicated to researching and producing consumer packaged goods products derived from its proprietary extract of the Amanita Muscaria mushroom, AME-1.

We seek Safe Harbor.

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