Filament Health (FH) will license its natural psilocybin to ATMA Journey Centers for use in clinical trials, including an upcoming phase I trial on healthy subjects, which has already received Health Canada approval.
Vancouver, British Columbia, January 31, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced Health Canada approval for a phase 2 clinical trial using PEX010, the Company’s botanical psilocybin drug candidate. Cybin Therapeutics (“CT”), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols, has licensed PEX010 (25 mg) from Filament for use in the trial. The trial is expected to begin in Q3’22 and will include individuals with major depressive disorder who are undergoing selective serotonin reuptake inhibitor (SSRI) therapy, commonly used to treat depression, as well as those who are SSRI-naive.
“Health Canada’s approval is a testament to both the validity of this trial as well as Filament’s ability to produce and license pharmaceutical-grade botanical drug candidates,” said Filament Chief Executive Officer, Benjamin Lightburn. “The effect of psilocybin therapy in patients taking traditional SSRI antidepressant medication is an extremely important investigation and we are thrilled to participate in this important research.”
“Many Canadians who battle depression undergo SSRI therapy, and until now, this has generally meant exclusion from psychedelic assisted psychotherapy (PAP) clinical trials,” said Josh Taylor, Founder of Cybin Therapeutics. “If it can be demonstrated that PAP can be safely and effectively given to patients on SSRIs, many will stand to benefit. We feel this is an outstanding opportunity to show Health Canada that Cybin Therapeutics can improve patient outcomes with our team and developed protocols.”
Filament has also licensed PEX010 (25 mg) to CT for additional phase 2 clinical trials, which are expected to begin in the fourth quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips.
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.
Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.
MEDIA CONTACT
Anna Cordon, Director of Communications
778.245.9067
anna@filament.health
Cybin Therapeutics
604.318.0458
info@cybintherapeutics.com
INVESTOR RELATIONS CONTACT
KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health
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.
Filament will license PEX010, its proprietary botanical psilocybin drug candidate, to Cybin Therapeutics for use in two upcoming Phase II clinical trials awaiting Health Canada approval
Vancouver, British Columbia, January 14, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that it has entered into a licensing agreement with Cybin Therapeutics (“CT”), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols to treat mild mood disorders and addictions. Under the agreement, Filament will license PEX010, its botanical psilocybin drug candidate, to CT for two upcoming Phase II clinical trials addressing depression and alcohol use disorder with an additional two planned for 2022. The financial terms were not disclosed.
CT filed a Clinical Trial Application (CTA) to Health Canada for the first trial in 2021, and anticipates its depression study to begin in the second quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips. Dr. Reg Peters has been involved in advocacy for compassionate use of psilocybin for palliative patients, including as a medical advisor to Therapsil. Mr. Dave Phillips, Training Advisor to Therapsil and a highly experienced psilocybin-assisted therapist, will lead the therapy component of the trials along with an experienced clinical team at Cybin Therapeutics’ purpose-built clinic.
“This agreement with Cybin Therapeutics demonstrates Filament’s ability to license our technology and facilitate our partners’ trials,” said Filament Chief Executive Officer, Benjamin Lightburn. “Our mission is to support the treatment of mental health conditions through the discovery and delivery of exclusively-natural psychedelic medicines, and we are proud to aid CT’s efforts. We view this as the first of many agreements in a long partnership.”
Josh Taylor, Cybin Therapeutics Founder, said “We are excited to advance our mission of creating psilocybin-based therapies for a number of treatment areas. Filament’s unique, all-natural drug candidates combined with our experienced team, we believe, create an ideal environment for creating research-based protocols, formulations, and outcomes for healing.”
BUSINESS DEVELOPMENT
Due to strong commercial demand for Filament’s unique proprietary drug candidates, the Company has engaged business development professionals to meet inbound requests and begin commercial outreach. Andry Tjahyana joins as Vice President, Business Development, bringing more than 25 years’ relevant experience. Filament has also engaged Thomas Ryan, Rob Grundy, and Christine Verstraate from NavigatorBIO, who bring a combined 65 years of pharmaceutical industry sales experience.
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
ABOUT CYBIN THERAPEUTICS
Cybin Therapeutics (“CT”), is a private therapeutic bioscience company established in 2019, on a mission to develop psilocybin-assisted therapeutic protocols and natural formulations to treat mild mood disorders and addictions. Cybin Therapeutics works with healthcare specialists who together form a dynamic clinical team with the ability to carry out studies and clinical trials for Cybin Therapeutics and it’s future partners looking to conduct psilocybin based studies and trials.
Learn more at www.cybintherapeutics.com.
MEDIA RELATIONS
Anna Cordon, Director of Communications
778.245.9067
anna@filament.health
Cybin Therapeutics
604.318.0458
info@cybintherapeutics.com
INVESTOR RELATIONS CONTACT
KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health
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.
Vancouver, British Columbia, December 1, 2021 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that it will participate in the following upcoming events in December 2021:
To schedule a one-on-one meeting with Filament’s management at the H.C. Wainwright Conference, please contact KCSA Strategic Communications at KCSA-investor-relations@filament.health or an H.C. Wainwright representative directly, or book meeting times through the H.C. Wainwright event platform.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)
FFilament 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.
MEDIA CONTACT
Anna Cordon, Director of Communications
778.245.9067
anna@filament.health
INVESTOR RELATIONS CONTACT
KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health
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.
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, British Columbia, November 15, 2021 – 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;
Third Quarter and Post Period Financial and Capital Markets Highlights
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.
Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.
MEDIA CONTACT
Anna Cordon, Director of Communications
778.245.9067
anna@filament.health
INVESTOR RELATIONS CONTACT
KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health
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.15
When psilocybin is consumed, it’s metabolized into psilocin, which is the compound that produces most or all of the psychedelic effects. Will the experience change if is psilocin is administered directly?
Filament Health (FH) just received FDA-approval for a first-of-its kind study that will reveal the answer.
The phase I trial at the University of California San Francisco will compare the effects psilocybin and psilocin in 20 healthy patients. Psilocybin will be administered orally, whereas psilocin will be administered both orally and sublingually, meaning it will be absorbed through tissues under the tongue.
Researchers predict that direct psilocin could result in faster onset times, greater consistency and bioavailability, and fewer side effects.
Vancouver, British Columbia, November 2, 2021 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), an exclusively-natural psychedelic drug discovery company, announces FDA authorization to initiate the first clinical trial using naturally-sourced psychedelic substances. In addition, this approval is the first for the direct administration of psilocin rather than its prodrug psilocybin and will administer Filament’s three proprietary botanical drug candidates. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF).
“We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates,” said Chief Executive Officer, Benjamin Lightburn. “Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation.”
The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament’s three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). As a result of the need for psilocybin to convert into psilocin before becoming active in the human body, the direct administration of psilocin may yield several therapeutic benefits such as faster onset time, greater consistency, increased bioavailability, and lessened side effects. These potential attributes are being studied in the authorized trial. In addition, psilocin is an ideal candidate for sublingual delivery because of the bypassing of the gut, where the conversion to psilocybin is thought to primarily occur. To date, synthetic manufacturers have been unable to produce a stable formulation of psilocin and enter it into a clinical trial.
“My team and I are very excited to begin dosing Filament’s drug candidates in our clinic,” said Dr. Josh Woolley, MD/Ph.D., Director of TrPR and the study’s Principal Investigator. “The oral and sublingual administration presents an opportunity to learn about psilocin’s effects compared to psilocybin and perhaps set a new standard for psychedelic assisted therapy.”
Further information about the history and benefits of psilocin can be found at https://filament.health/psilocybin-vs-psilocin.
ABOUT FILAMENT HEALTH
Filament Health is an exclusively-natural psychedelic drug discovery and extraction technology company. Its mission is to see safe, approved, natural psychedelics in the hands of everyone who needs them as soon as possible. Filament believes measurable and efficacious medicines will be a catalyst to addressing many of the world’s mental health problems and that natural psychedelics provide an optimal option for widespread adoption of these substances. Filament engages in natural extraction technology commercialization, utilizing its intellectual property portfolio, and its subsidiary Psilo Scientific’s in-house GMP facility, and Health Canada Dealer’s License for all natural psychedelics. Filament is headquartered in Vancouver, British Columbia and trades on the OTCQB Venture Market (OTCQB:FLHLF), Canada’s NEO Exchange (NEO:FH), and the Frankfurt Stock Exchange (FSE:7QS).
Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.
MEDIA RELATIONS
Anna Cordon, Director of Communications
778.245.9067
anna@filament.health
INVESTOR RELATIONS CONTACT
KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
FilamentIR@KCSA.com
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.
