Filament announced FDA approval for the first clinical trial using naturally-sourced psychedelic substances in November 2021
The Company signed multiple revenue-generating licensing agreements allowing partners to use its natural psilocybin drug candidate for clinical trials
VANCOUVER, BC, March 31, 2022 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, released its fourth quarter financial results and operational highlights for the period ended December 31, 2021.
"During the fourth quarter, we expanded our partnership network with two licensing agreements, and continued to build our drug development platform and infrastructure," said Ben Lightburn, Co-Founder and CEO.
Mr. Lightburn continued: "Since the quarter ended, our efforts have proven productive, including the issuance of a second patent for extraction and standardization of natural psilocybin, the expansion of the Health Canada Dealer's License held by our subsidiary Psilo Scientific, and Psilo's inclusion on the Health Canada list of licensed psilocybin producers."
Operational Highlights During and Subsequent to Q4 2021:
- FDA authorization of a Phase I clinical trial which will be the first clinical trial using naturally-sourced psychedelic substances and the first direct administration of psilocin rather than its prodrug psilocybin;
- Entered into a co-development and exclusive licensing agreement with EntheoTech to provide PEX010 (25 mg) for two of EntheoTech's upcoming clinical trials;
- Partnered with the Canadian Centre for Psychedelic Science and the University of Toronto to provide PEX010 (1 mg) for its Phase II clinical trial, which obtained Health Canada approval December 31st, 2021.
Financial and Capital Market Highlights During and Subsequent to Q4 2021:
- Cash and cash equivalents of $4.6 million and working capital of $5.0 million as of December 31, 2021;
- Cash used in operating activities of $5.4 million during the twelve months ended December 31, 2021;
- Q4 cash disbursements included $890 thousand payment to UCSF for Filament's Phase I clinical trial.
- Listed on the Frankfurt Stock Exchange ("FSE") under the symbol FSE:7QS on October 15, 2021;
- Uplisted to the OTCQB Market under the symbol FLHLF and received depository Trust Company ("DTC") eligibility on October 12, 2021.
Subsequent to Q4 2021
- Issued 99,844 common shares to a service provider in exchange for the reduction of $39,938 in debts owing;
- Issued 1,650,000 options to purchase common shares to six parties with exercise prices ranging $0.30 to $0.40 and term to expiry of two to five years;
- Issued 226,000 restricted share unit awards, under which the holders have the right to receive an aggregate of 226,000 common shares;
- Issued 270,000 common shares upon the exercise of 270,000 options resulting in proceeds of $100,000.
Business Development Activities Subsequent to Q4 2021
- Expanded management team adding Andry Tjahyana as Vice President, Business development as well as experienced pharmaceutical industry sales personnel;
- Entered into a licensing agreement with Cybin Therapeutics to provide PEX010 (25 mg) for two of Cybin Therapeutics' upcoming Phase II clinical trials;
- Phase II clinical trial obtained Health Canada approval that will include individuals with major depressive disorder who are undergoing SSRI therapy;
- Entered into a licensing agreement with ATMA Journey Centers to provide PEX010 (25 mg) for its Phase I trial which has obtained Health Canada approval and will include healthy individuals enrolled in a psychedelic assisted therapy training program.
Other Corporate Activities Subsequent to Q4 2021
- Announced Psilo's inclusion in a Health Canada list of licensed psilocybin producers that is available upon request to parties interested in access to psilocybin through the Special Access Program or for scientific research;
- Received a shipment of psychedelic mushrooms from a private company located in Uruguay;
- Psilo Scientific Ltd., Filament's wholly-owned subsidiary received an amendment to its existing Health Canada Dealer's License allowing the possession, production, research, supply and delivery of additional controlled substances;
- Issued a second patent by the Canadian Intellectual Property Office for the extraction and standardization of natural psilocybin and associated psychedelic compounds complementing Filament's patent portfolio focused on extraction methods, purification processes, standardization processes, stabilization processes as well as methods and formulations for delivering psychoactive alkaloids.
- Announced the promotion of Ryan Moss to Chief Science Officer.
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 intellectual property 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.
Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.
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. Forward-looking statements herein include, but are not limited to, statements regarding the benefits of psilocin as compared to psilocybin. 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. 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 results of the clinical trial. 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.