Psyched Wellness Provides Comprehensive Investor Update

Executive Summary

• Psyched Wellness completed an initial production run of its new “Santa” dietary supplement shot and plans a second run for mid‑October to support holiday inventory.
• The company submitted a New Dietary Ingredient Notification (NDIN) to the FDA for its proprietary Amanita muscaria extract (AME‑1); the FDA did not grant safety concurrence but the filing does not block market sales.
• A scaled‑up extraction process patent application was filed in the U.S. and is pending in both the United States and Canada; a six‑month accelerated stability study confirmed an 18‑month shelf life for AME‑1.

Key Details

• Product Development:
• Initial production run of “Santa” dietary supplement shot completed on September 15, 2025; soft launch scheduled for October 1, 2025.

• Second production run slated for mid‑October 2025 to ensure sufficient holiday inventory.

• Scientific Studies:

• Genotoxicity study (AMES test, in‑vitro TK‑MLA assay, micronucleus assay) on AME‑1 initiated March 14, 2025 – progress described as promising.

• Six‑month accelerated stability study by third‑party lab showed AME‑1 retains muscimol content for up to 18 months with no microbial growth; product “Calm” now carries an 18‑month shelf life.

• Patents:

• Filed U.S. Patent Application No. 19/157,676 on August 18, 2025 for a scaled‑up extraction process; application pending in the United States and Canada.

• Regulatory Update:

• Voluntarily submitted NDIN to FDA for AME‑1 in July 2025.
• FDA response (September 2025) indicated the data did not demonstrate that AME‑1 “will reasonably be expected to be safe,” but under the FFDCA an NDIN does not require FDA approval for market entry.

• Company maintains confidence in safety based on historical use and internal toxicology studies; asserts continued compliance with FFDCA.

• Commercial Outreach:

• Seeking additional route‑to‑market partners nationwide; contact [email protected] for distribution/listing of “Calm.”

Notable Quotes

• “We remain 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…” – Jeffrey Stevens, CEO.