- Study conducted under U.S. FDA Investigational New Drug (IND) authorization by Dr. Anthony Back at the University of Washington
- Second psilocybin session showed meaningful improvements in anxiety, depression, and overall psychological outcomes, with effects lasting up to 24 weeks
- 69% of participants fell below clinical thresholds for anxiety and depression after second treatment
- Research builds on prior studies utilizing Filament's botanical psilocybin drug candidate, PEX010
- No serious adverse events reported, even with higher dosing and optional booster administration
- PEX010 now supplied to 70+ clinical sites globally, supporting trials in depression, PTSD, and cancer-related distress
- Companies applaud recent U.S. executive action supporting psychedelic research, reinforcing momentum toward regulated, science-driven treatments
Toronto, Ontario--(Newsfile Corp. - April 20, 2026) - Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) ("Red Light" or the "Company"), in connection with its proposed acquisition of Filament Health Corp. ("Filament"), is highlighting newly published clinical research that may signal an important shift in the evolution of psychedelic medicine, from single-use interventions toward repeatable, protocol-driven treatment models.
A Phase 1 clinical study published in April 2026 in Frontiers in Public Health (link here), conducted under U.S. FDA Investigational New Drug authorization as an investigator-initiated study led by Dr. Anthony Back at the University of Washington evaluated the effects of a second psilocybin-assisted therapy session in patients with metastatic cancer who had only partially responded to an initial treatment. The results showed that a second guided session produced meaningful improvements in psychological outcomes, suggesting that a second experience at a higher dose and no antidepressant tapering may be beneficial for partial responders.
This study is a follow-on to earlier clinical research conducted by Dr. Anthony Back, which evaluated the group-based psilocybin-assisted therapy model using Filament's botanical candidate, PEX010 (https://journals.sagepub.com/doi/10.1177/28314425251413856). Both of Dr Back's studies were funded by the Steven and Alexandra Cohen Foundation, with Filament Health providing the PEX010 psilocybin capsules.
Patients in the study experienced clinically significant reductions in anxiety and depression, with mean Hospital Anxiety and Depression Scale (HADS) scores improving from 15.08 at baseline to 9.00 within eight days following the second session, with benefits sustained for up to 24 weeks. Notably, 69% of participants fell below the clinical threshold for anxiety and depression after the second treatment. The proportion of participants reporting a "complete mystical experience" (a factor often associated with stronger therapeutic outcomes) increased from 38% during the first session to 77% in the second. Improvements in social connection, psychological well-being, and group cohesion were also observed and persisted for several months. No serious adverse events were reported, even with higher dosing and optional booster administration.
The study was conducted using a structured group retreat model that included preparatory sessions, supervised dosing, and integration support, with cohorts of up to eight participants. This format is increasingly relevant as the industry looks for ways to reduce costs and expand access, particularly given the significant time and resource requirements associated with traditional one-on-one psychedelic therapy. The authors concluded that a partial response to an initial psilocybin experience should not be considered treatment failure and that retreatment and dose optimization may play a meaningful role in improving patient outcomes.
These findings come at a time when Filament's botanical psilocybin drug candidate, PEX010, continues to expand its global clinical footprint. PEX010 has now been supplied to more than 70 clinical research sites worldwide and is being used across a range of studies, including trials focused on depression, PTSD, and cancer-related distress. Recent progress includes new international licensing agreements and additional research shipments supporting ongoing and planned clinical trials, including those evaluating repeat dosing strategies.
"This is where the science, and now policy, is starting to align," said Todd Shapiro, Chief Executive Officer of Red Light Holland. "With the U.S. government taking meaningful steps to accelerate research and regulatory pathways for psychedelic therapies, including compounds targeting serious mental health conditions and addiction, it reinforces what many in the space have long believed. If psilocybin therapy ultimately proves to work best across multiple sessions, that has significant implications for both patient care and how this category evolves. Through Filament's PEX010 and our broader platform, we believe we are well positioned to support that shift as clinical models advance and access continues to expand."
Benjamin Lightburn, Chief Executive Officer of Filament, added: "As clinical protocols become more refined, consistency of supply becomes increasingly important. We're seeing growing demand from researchers and institutions for standardized, naturally-derived psilocybin, and our expanding network reflects that."
Taken together, the emergence of clinical evidence supporting repeat treatment, combined with a growing global supply and research infrastructure, points toward a model of psychedelic therapy that is more structured, scalable, and aligned with broader healthcare systems. As the field continues to mature, the ability to support multi-session treatment frameworks may become a defining factor in how these therapies are ultimately delivered.
U.S. Policy Momentum Supporting Psychedelic Research
Red Light and Filament Health applaud the United States' recent executive action supporting the advancement of psychedelic research, recognizing it as a significant step toward unlocking innovative, science-driven mental health treatments for Americans. Both companies have consistently championed safe, regulated access grounded in clinical evidence, with Filament Health previously achieving a key milestone through its ethically sourced, Nagoya Protocol, compliant importation of iboga for pharmaceutical development, helping advance research into ibogaine's therapeutic potential. As momentum builds across the U.S. regulatory landscape, Red Light and Filament Health are actively exploring opportunities to responsibly develop and potentially commercialize their intellectual property portfolios, including patented drug candidates such as PEX010, while continuing to expand scientific understanding and uphold the highest standards of patient safety.
About Red Light Holland
Red Light Holland is an Ontario-based organization advancing a focused strategy within the legal psychedelic sector, centered on consensual data collection and R&D initiatives designed to expand naturally occurring drug development, understanding of psilocybin use and consumer experiences. In parallel, the Company operates commercial activities across Europe and North America, including psilocybin truffle sales in the Netherlands' legal market and mushroom home grow kits offered through B2B and DTC channels, in compliance with applicable laws.
About Filament Health
Filament Health is a clinical-stage natural psychedelic drug development company. Filament believes that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and its 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. Filament is paving the way with the first-ever natural psychedelic drug candidates.
For additional information on Red Light Holland:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@redlight.co
Website: www.RedLight.co
For additional information on Filament:
Benjamin Lightburn
Chief Executive Officer & Director
Email: ben@filament.health
Website: www.filament.health
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current conditions but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company's control. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its respective subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Examples of such information include statements with respect to: the potential implications of multi-session psilocybin therapy models for patient care and the broader psychedelic medicine category; the anticipated benefits of structured, repeatable treatment protocols using psilocybin; the continued expansion of PEX010's clinical network and global supply infrastructure; the growing demand from researchers and institutions for standardized, naturally-derived psilocybin; the Company's pending acquisition of Filament Health and the expected integration of Filament's clinical infrastructure and intellectual property; the future development, commercialization, and regulatory approval of PEX010; and the potential for multi-session treatment frameworks to become a defining factor in how psychedelic therapies are delivered.
Forward-looking information in this news release is based on certain assumptions and expected future events, namely: the continued ability of Filament to supply PEX010 to clinical research sites and compassionate use programs; the continued progression of clinical studies evaluating psilocybin-assisted therapy, including multi-session and repeat-dosing protocols; the successful completion of the Company's pending acquisition of Filament Health on the terms contemplated; the ability to maintain effective relationships with clinical partners, research collaborators, and regulatory bodies; the continued regulatory authorization of PEX010 for clinical use in applicable jurisdictions; and general business, market and economic conditions.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, namely: regulatory or enforcement developments affecting the legal framework for psilocybin research, clinical trials, and therapeutic use; the risk that the pending acquisition of Filament Health is not completed on the terms contemplated or at all; the risk that clinical studies, including those evaluating multi-session psilocybin therapy, do not progress as anticipated or do not produce favorable results; the risk that additional license agreements, research shipments, or regulatory authorizations do not materialize as expected; adverse changes in the regulatory or political landscape affecting psychedelic research in any jurisdiction; the risk that psilocybin-assisted therapy does not gain broader acceptance within mainstream healthcare systems; the risk that existing or future competitors develop alternative products or approaches that reduce demand for PEX010; and general risks related to the Company's business, financial condition, and results of operations as more fully described in the Company's continuous disclosure filings.
Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.
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