Latest news with #FilamentHealth
Cision Canada
3 hours ago
- Business
- Cision Canada
FILAMENT HEALTH ANNOUNCES SECOND QUARTER 2025 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
VANCOUVER, BC, Aug. 11, 2025 /CNW/ - Filament Health Corp. (OTC: FLHLF) (" Filament" or the " Company"), a clinical‐stage natural psychedelic drug development company, released its second quarter financial results and operational highlights for the period ended June 30, 2025. "This quarter, we took deliberate steps to position Filament Health for long-term growth, including streamlining our public listings to reduce costs and increase operational efficiency. We advanced our clinical and licensing portfolio with two significant developments: securing an exclusive global license for intellectual property and data usage from a Phase 2 study of psilocybin as a treatment for cocaine use disorder, and receiving approval to initiate a Phase 2 trial of our botanical psilocybin drug candidate, PEX010, for the treatment of prolonged brief disorder in Sweden," said Benjamin Lightburn, Chief Executive Officer and Co-Founder at Filament Health. "These achievements reflect our commitment to pioneering psychedelic drug development while managing our resources strategically, ensuring that we are well-positioned to continue delivering on our mission. The demand for botanical psychedelic treatments continues to grow as noted by the recent approval of PEX010 for compassionate use in Germany for administration to a patient suffering from treatment-resistant depression (TRD) - the EU's first ever approval of psilocybin for compassionate use." Q2 2025 Financial Highlights: On May 28, 2025, the Company's common shares shifted from the OTCQB Venture Market to the OTC Pink Limited Information tier, and its listing on the Frankfurt Stock Exchange was terminated. On May 6, 2025, the Company held a Special Meeting for the voluntary delisting of its common shares from CBOE Canada, which was approved by shareholder vote, and the Company was delisted from the CBOE Canada Exchange as of May 21, 2025. On April 9, 2025, the Company closed a financing of $961,275 further to the issuance of units, comprised of a secured convertible debenture of the company and a warrant. Cash and cash equivalents of $679,972; Cash used in operating activities of $592,136; and total revenues of $259,013. Q2 2025 Operational Highlights: On June 17, 2025, the Company announced that it entered into an exclusive global license agreement with the University of Alabama at Birmingham for intellectual property related to a recently completed Phase 2 placebo-controlled clinical trial of psilocybin as a treatment for cocaine use disorder. On June 11, 2025, the Company announced that the Swedish Ethical Review Authority and Swedish Medical Products Agency have authorized a double-blind Phase 2 clinical trial studying its botanical psilocybin drug candidate, PEX010, at Linkoping University, for the treatment of prolonged grief disorder. ABOUT FILAMENT HEALTH (OTC:FLHLF) 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 and on X, 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. 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 the impact of the patent on the Company's business and the ability of the Company to secure future patents. 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 status of patent applications and the ability to secure patents. 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.
Cision Canada
31-07-2025
- Health
- Cision Canada
FILAMENT HEALTH ANNOUNCES FIRST-EVER COMPASSIONATE USE APPROVAL FOR PSILOCYBIN IN THE EUROPEAN UNION
Filament's botanical psilocybin drug candidate PEX010 to be administered in Germany for treatment-resistant depression VANCOUVER, BC, /CNW/ - Filament Health Corp. (OTC:FLHLF) (" Filament" or the " Company"), a clinical‐stage natural psychedelic drug development company, today announced the first-ever approval for compassionate use of psilocybin in the European Union (EU). The Company's botanical psilocybin drug candidate, PEX010, has been authorized for administration to a patient suffering from treatment-resistant depression (TRD) in Germany. The approval was granted under Germany's compassionate use framework and marks the first time psilocybin will be prescribed outside of a clinical trial in the EU. The treatment will be conducted by Dr. Gerhard Gründer at the Central Institute of Mental Health, Department of Molecular Neuroimaging. "This is a landmark moment for the field of psychedelic medicine in the European Union. Treatment-resistant depression affects up to 30% of individuals diagnosed with major depressive disorder and remains one of the most difficult psychiatric conditions to treat. Psilocybin has demonstrated significant promise as a novel therapeutic option, and this approval marks an important step toward expanding access for those in urgent need," said Dr. Gerhard Gründer. "I am honoured to play a role in expanding European access to psilocybin and grateful to the team at Filament Health for their support." "The approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament's position as the world's leading supplier of GMP-quality psychedelic drug candidates," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "We're incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It's a validation of Filament's ongoing efforts to make safe, standardized psychedelic medicines available to those who need them most." ABOUT FILAMENT HEALTH (OTC:FLHLF) 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 and on X, Instagram, and LinkedIn. FORWARD LOOKING INFORMATION Certain statements and information contained in this press release and the documents referred to 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. 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 the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. 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.
Cision Canada
24-07-2025
- Health
- Cision Canada
FILAMENT HEALTH ANNOUNCES TWO PHASE 2 RESEARCH TRIALS IN PARTNERSHIP WITH UNIVERSITY COLLEGE LONDON
UCL will study PEX010, the company's botanical psilocybin drug candidate, in trials investigating human perception, cognition, and therapeutic optimization VANCOUVER, BC, July 24, 2025 /CNW/ - Filament Health Corp. (OTC: FLHLF) (" Filament" or the " Company"), a clinical‐stage natural psychedelic drug development company, today announced that it has partnered with University College London (UCL) to supply its botanical psilocybin drug candidate, PEX010, for two phase 2 research trials. The Medicines and Healthcare Products Regulatory Agency (MHPRA)-approved trials will explore the effects of PEX010 on brain function, perception, and psychological wellbeing. "These studies represent two important frontiers in psychedelic research," said Dr. Jeremy I Skipper, Principal Investigator for both trials and Professor at UCL. "We will examine both how preparation methods influence therapeutic and cognitive outcomes, and how psilocybin interacts with sensory and cognitive systems to shape perception. Together, these studies offer valuable insight into the therapeutic potential and fundamental mechanisms of psychedelic compounds. They would not be possible without the support of Filament Health." The first of the two trials, led by Rosalind McAlpine, is a randomised controlled study evaluating the impact of the Digital Intervention for Psychedelic Preparation, a novel 21-day self-guided programme designed to enhance therapeutic outcomes of psychedelic experiences. Participants are randomly assigned to one of two structured preparatory pathways: a meditation-based intervention or a music-based control condition, both delivered through the same digital platform. Following the 21-day programme, all participants undergo a supervised 25 mg psilocybin session at UCL. The study aims to assess how different preparatory strategies influence the quality of the psychedelic experience, levels of psychological readiness, and changes in mental wellbeing. In addition to these outcomes, the trial evaluates intervention adherence, user engagement, and the acceptability of the digital platform - informing the design of future large-scale efficacy trials. The second trial, led by Oris Shenyan, Amplifying Experimentall y Induced Hallucinations With "Micro" Doses of Psilocybin, will explore how low doses of psilocybin affect the perception of geometric hallucinations and pareidolia, which is the tendency to see meaningful patterns in ambiguous stimuli – such as seeing faces in clouds. Building on models of excitatory visual cortex dynamics, the study will assess how low dose psilocybin-induced neural excitation interacts with external sensory input to shape hallucinatory experiences under controlled conditions. "Understanding how preparation style and dose affect the psychedelic experience is vital for advancing safe, effective psychedelic therapies," said Benjamin Lightburn, Chief Executive Officer and Co‐Founder at Filament Health. "We are proud to support these pioneering studies at one of the world's preeminent research institutions." PEX010 is authorized for investigation in 53 clinical trials worldwide for 14 mental health indications. ABOUT FILAMENT HEALTH (OTC:FLHLF) 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 and on X, Instagram, and LinkedIn. FORWARD LOOKING INFORMATION Certain statements and information contained in this press release and the documents referred to 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. 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 the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. 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.
Malaysian Reserve
07-07-2025
- Health
- Malaysian Reserve
FILAMENT HEALTH ANNOUNCES FDA AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING PSILOCYBIN FOR ALCOHOL USE DISORDER AND POST-TRAUMATIC STRESS DISORDER IN VETERANS AND FIRST RESPONDERS
The clinical trial at the University of Washington will study Filament's botanical psilocybin drug candidate, PEX010 VANCOUVER, BC, July 7, 2025 /CNW/ – Filament Health Corp. (OTC:FLHLF) ('Filament' or the 'Company'), a clinical-stage natural psychedelic drug development company, today announced that the U.S. Food and Drug Administration (FDA) has authorized a phase 2 clinical trial studying the Company's botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in military veterans and first responders. The trial will be led by Dr. Nathan Sackett at the University of Washington School of Medicine's Center for Novel Therapeutics in Addiction Psychiatry. It will be the first clinical trial to study the safety of psilocybin combined with psychological support for the treatment of individuals with both AUD and PTSD. 'Despite significant overlap between AUD and PTSD, there is a lack of evidence-based treatment options for people experiencing both conditions, particularly among veterans and first responders, who are disproportionately affected,' said Dr. Sackett, Principal Investigator and Assistant Professor in the Department of Psychiatry and Behavioral Sciences. 'This study will be the first to investigate the safety of psilocybin-assisted support in this dual-diagnosis population, and we are grateful to Filament for enabling this important research.' Military veterans and first responders experience some of the highest rates of co-occurring AUD and PTSD, yet treatment options remain limited and are often ineffective. While psychedelic-assisted therapies have shown promise for each condition individually, no prior trials have evaluated the use of psilocybin for both concurrently. This study will assess the safety of a single 25 mg dose of PEX010 paired with non-directive psychological support, defined by safety monitoring, empathetic presence, and integration sessions. 'Veterans and first responders dedicate their lives to protecting others, yet are often left behind with regard to mental health treatments,' said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. 'We're proud to contribute to this urgently needed research, which could help shape the future of care for those who have given so much to their communities.' The trial is funded by the State of Washington and is enrolling now, with results expected by fall 2026. Information regarding enrolment can be found at ABOUT FILAMENT HEALTH (OTC:FLHLF)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 and on Twitter, Instagram, and LinkedIn. FORWARD LOOKING INFORMATIONCertain statements and information contained in this press release and the documents referred to 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. 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 the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. 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.
Cision Canada
07-07-2025
- Health
- Cision Canada
FILAMENT HEALTH ANNOUNCES FDA AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING PSILOCYBIN FOR ALCOHOL USE DISORDER AND POST-TRAUMATIC STRESS DISORDER IN VETERANS AND FIRST RESPONDERS
The clinical trial at the University of Washington will study Filament's botanical psilocybin drug candidate, PEX010 VANCOUVER, BC, July 7, 2025 /CNW/ - Filament Health Corp. (OTC:FLHLF) (" Filament" or the " Company"), a clinical-stage natural psychedelic drug development company, today announced that the U.S. Food and Drug Administration (FDA) has authorized a phase 2 clinical trial studying the Company's botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in military veterans and first responders. The trial will be led by Dr. Nathan Sackett at the University of Washington School of Medicine's Center for Novel Therapeutics in Addiction Psychiatry. It will be the first clinical trial to study the safety of psilocybin combined with psychological support for the treatment of individuals with both AUD and PTSD. "Despite significant overlap between AUD and PTSD, there is a lack of evidence-based treatment options for people experiencing both conditions, particularly among veterans and first responders, who are disproportionately affected," said Dr. Sackett, Principal Investigator and Assistant Professor in the Department of Psychiatry and Behavioral Sciences. "This study will be the first to investigate the safety of psilocybin-assisted support in this dual-diagnosis population, and we are grateful to Filament for enabling this important research." Military veterans and first responders experience some of the highest rates of co-occurring AUD and PTSD, yet treatment options remain limited and are often ineffective. While psychedelic-assisted therapies have shown promise for each condition individually, no prior trials have evaluated the use of psilocybin for both concurrently. This study will assess the safety of a single 25 mg dose of PEX010 paired with non-directive psychological support, defined by safety monitoring, empathetic presence, and integration sessions. "Veterans and first responders dedicate their lives to protecting others, yet are often left behind with regard to mental health treatments," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "We're proud to contribute to this urgently needed research, which could help shape the future of care for those who have given so much to their communities." The trial is funded by the State of Washington and is enrolling now, with results expected by fall 2026. Information regarding enrolment can be found at ABOUT FILAMENT HEALTH (OTC:FLHLF) 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 and on Twitter, Instagram, and LinkedIn. FORWARD LOOKING INFORMATION Certain statements and information contained in this press release and the documents referred to 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. 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 the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. 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.
