Psyched Wellness Provides Comprehensive Investor Update
Toronto, Ontario - Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the "Company" or "Psyched"), a life sciences company specializing in the production and distribution of health and wellness products derived from the Amanita Muscaria mushroom, is pleased to provide the following corporate update to its investors.
Product Development & 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 September 15, 2025, the Company completed an initial production run in preparation for a soft launch on October 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, we engaged a third-party laboratory to conduct a six-month accelerated and 24-month real-time stability study on AME-1. The goal was to evaluate the potential extension of product shelf life beyond the current 12-month period. Results confirmed that AME-1 maintains muscimol content up to 18 months under real-time conditions and shows no microbial growth under either accelerated or real-time conditions through 24 months. 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 August 18, 2025, as U.S. 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 favorable 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 their route-to-market partnerships, throughout the nation. If you are interested in distributing/listing Calm, please reach out to sales@psyched-wellness.com.