FDA Authorization of Historic Phase I Clinical Trial Using All-Natural Psychedelic Compounds and
Direct Psilocin Administration for the First Time
Granted First and Only Patent for Extraction and Standardization of Natural Psilocybin
Health Canada Dealer's License Enables Production and Distribution of All Natural cGMP-Grade
Psychedelic Supply from its Facilities
VANCOUVER, BC, Nov. 15, 2021 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, released its third quarter financial results and operational highlights for the period ended September 30, 2021.
Third Quarter and Post Period Operational Highlights
- FDA authorization of phase I clinical trial using naturally-sourced psychedelic substances and direct administration of psilocin (both orally and sublingually) for the first time in FDA history;
- First and only patent granted for the extraction and standardization of natural psilocybin;
- Over 20 patent applications to-date, including three international Patent Cooperation Treaty (PCT) applications covering extraction, standardization, purification and delivery of botanical drug candidates;
- Completed industry-first export of current good manufacturing practices ("cGMP")-quality natural psychedelic substances to the United States;
- Psilo Scientific Ltd., Filament's wholly-owned subsidiary received an amendment to Health Canada Dealer's License for its facility, allowing the possession, production, and delivery of all controlled natural psychedelic substances;
- Produced pharmaceutical-grade batches of natural psilocybin extracts including leading drug candidates which will be entered into upcoming FDA clinical trials.
Third Quarter and Post Period Financial and Capital Markets Highlights:
- Uplisted to the OTCQB Market under the symbol FLHLF on October 12, 2021;
- Received Depository Trust Company ("DTC") eligibility on October 12, 2021;
- Listed on the Frankfurt Stock Exchange ("FSE") under the symbol FSE:7QS on October 15, 2021;
- Cash and cash equivalents of $6.4 million as of September 30, 2021.
Commentary and Outlook
"To-date, we have distinguished ourselves as a leader in the extraction and drug development of all-natural psychedelic compounds through our patent-protected botanical extraction process and recent FDA approval of the first-ever clinical trial using all-natural psychedelics to treat a variety of mental health disorders," said Benjamin Lightburn, Chief Executive Officer. "Our team continues to quickly execute on Filament's operational milestones, supported by our industry partnerships, extraction expertise and long-term IP strategy. Our goal is to continue our momentum by advancing our novel psilocybin and psilocin compounds through clinical trials, further building out our IP protection, and establishing ourselves as a unique provider of all-natural pharmaceutical-grade psychedelics to the industry. We are committed to maintaining this pace of innovation in order to support the treatment of mental health conditions with safe, natural psychedelics as soon as possible."
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary technology platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
FORWARD LOOKING INFORMATION
Certain statements and information contained herein may constitute "forward-looking statements" and "forward-looking information," respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament's upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements 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 statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.