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Rhelion Life Sciences Signs Agreement with University Health Network for Randomized Clinical Trial of Psilocybin in Parkinson's Disease Depression

(Very High)
(Positive)

Rhelion Life Sciences (OTCQB: TRUFF), through its wholly owned subsidiary Filament Health, has signed a licence agreement with University Health Network (UHN) in Toronto to supply its patented, naturally derived psilocybin drug candidate PEX010 for the randomized clinical trial PSI-PARK.

According to Rhelion Life Sciences, PSI-PARK (“Evaluating the Use of Psilocybin to Treat Parkinson's Depression: A Randomized Clinical Trial”) will study psilocybin for depression in people with Parkinson’s disease. UHN sponsors the trial, with Dr. Joshua Rosenblat as principal investigator; Filament supplies PEX010 but is not responsible for trial conduct.

The company highlights Parkinson’s depression as a significant unmet need and notes prior open-label pilot data showing sustained mood improvements without serious adverse events. PEX010 supports more than 80 research studies worldwide and is produced under GMP with standardized doses from 0.5 mg to 25 mg. On April 30, 2026, Rhelion completed its acquisition of Filament, adding 76 issued patents across 15 families and consolidating PEX010 as its lead drug candidate.

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Positive

  • Licence agreement with UHN to supply PEX010 for the PSI-PARK randomized clinical trial in Parkinson’s disease depression
  • PEX010 supports more than 80 academic and philanthropic research studies worldwide as a standardized, GMP-manufactured psilocybin drug candidate
  • Filament acquisition completed April 30, 2026, adding 76 issued patents across 15 patent families and lead candidate PEX010 to Rhelion’s portfolio

Negative

  • None.

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  • Filament Health's patented, naturally derived psilocybin drug candidate PEX010 will be supplied to PSI-PARK, an investigator initiated randomized clinical trial evaluating psilocybin for the treatment of depression in Parkinson's disease.

Toronto, Ontario--(Newsfile Corp. - August 14, 2026) - Rhelion Life Sciences Corp. (CSE: RHEL) (FSE: 4YX) (OTCQB: TRUFF) ("Rhelion" or the "Company") an Ontario-based organization advancing innovation and research within the legal psychedelic sector. Through its wholly owned subsidiary Filament Health Corp. ("Filament"), the Company develops, manufactures and supplies PEX010, its patented, standardized, GMP manufactured botanical psilocybin drug candidate, to clinical research and compassionate access programs at leading institutions worldwide.

The Company is pleased to announce that Filament has entered into a licence agreement with University Health Network ("UHN") in Toronto for the supply of PEX010 to an investigator initiated clinical trial titled "Evaluating the Use of Psilocybin to Treat Parkinson's Depression: A Randomized Clinical Trial" ("PSI-PARK").

PSI-PARK is a randomized clinical trial evaluating psilocybin for the treatment of depression in people living with Parkinson's disease. The study is sponsored by UHN and will be conducted by the principal investigator, Dr. Joshua Rosenblat, and researchers at UHN. Filament will supply PEX010 for use in the study as the investigational drug product. Note, Filament is not the sponsor of the trial and is not responsible for its conduct.

Depression affects a substantial proportion of people living with Parkinson's disease and is among the strongest predictors of functional decline and reduced quality of life. It responds poorly to existing antidepressant treatment, and people with neurodegenerative disease have historically been excluded from psychedelic clinical research on safety grounds, leaving the therapeutic potential of psilocybin in this population largely unexamined. Depression in Parkinson's disease therefore represents a significant unmet clinical need in an area where the scientific question remains genuinely open.

PSI-PARK adds to an emerging body of clinical research in this indication. In April 2025, results of an open label pilot study in people with mild to moderate Parkinson's disease and mood dysfunction were published in Neuropsychopharmacology, reporting the first clinical data on psilocybin in any neurodegenerative disease. No serious adverse events were observed, and improvements in depression and anxiety measures were sustained to the final assessment. A larger randomized trial in the same indication is now underway.

PEX010, Filament Health's botanical psilocybin drug candidate, underscores Filament's position as a leading supplier of pharmaceutical grade natural psilocybin, supporting more than 80 academic and philanthropic research studies worldwide. PEX010 is available in a standardized dosing range of 0.5, 1, 5 and 25 mg from a single drug candidate, produced using Filament's proprietary extraction, purification and stabilization methods, giving investigators consistent composition across every dose, every study and every research site. On April 30, 2026, the Company completed its previously announced acquisition of Filament Health Corp., including its portfolio of 76 issued patents across 15 patent families and its lead drug candidate, PEX010.

About Rhelion LIfe Sciences:

Rhelion Life Sciences is a science and research led company advancing the natural psychedelic drug discovery and development sector. Through its wholly owned subsidiary Filament Health Corp., the Company is developing naturally derived psilocybin drug candidates, including its patented PEX010, and supporting clinical research and compassionate use programs with leading institutions around the world.

For additional information:

Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@rhelion.com
Website: www.Rhelion.com

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. Examples of such information include statements with respect to: the supply of PEX010 to the PSI-PARK study; the conduct, initiation and progress of the PSI-PARK study at University Health Network; the expansion of Filament's clinical research footprint in Canada and other jurisdictions; the therapeutic potential of psilocybin in depression associated with Parkinson's disease and other neurodegenerative conditions; the expected demand for standardized, naturally derived psilocybin; the availability of the standardized dosing range of 0.5, 1, 5 and 25 mg of PEX010; the completed acquisition of Filament Health and the expected integration of Filament's clinical infrastructure and intellectual property; the Company's corporate name change and any related changes to its trading symbols; and the future development, commercialization, and regulatory approval of PEX010.

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; the performance by University Health Network and the Company of their respective obligations in connection with the supply of PEX010; the continued progression of the PSI-PARK study; the successful integration of Filament Health following the completed acquisition; the ability to obtain and maintain any required regulatory permits and approvals, including clinical trial, ethics, import and export authorizations; 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 supply and research; the risk that integration of Filament Health is not completed as anticipated; the risk that anticipated supply in connection with the PSI-PARK study does not materialize as expected; the risk that the PSI-PARK study does not proceed, enrol or progress as anticipated; the risk that the study does not produce positive or clinically meaningful results; delays in regulatory permitting, including clinical trial, ethics, import and export authorizations; and adverse changes in the regulatory or political landscape affecting psychedelic research and access.

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.

Source: Rhelion Life Sciences Corp.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/309650

FAQ

What agreement did Rhelion Life Sciences (OTCQB: TRUFF) announce with University Health Network in August 2026?

Rhelion Life Sciences announced that its subsidiary Filament Health entered a licence agreement with University Health Network to supply PEX010. According to Rhelion, PEX010 will be used as the investigational psilocybin drug product in the PSI-PARK randomized clinical trial in Parkinson’s disease depression.

What is the PSI-PARK randomized clinical trial involving Rhelion Life Sciences’ PEX010 for Parkinson's disease depression (TRUFF)?

PSI-PARK is a randomized clinical trial titled “Evaluating the Use of Psilocybin to Treat Parkinson's Depression.” According to Rhelion, the UHN-sponsored study will evaluate psilocybin for depression in people living with Parkinson’s disease, using PEX010 as the investigational drug product supplied by Filament Health.

What role does Filament Health play in the PSI-PARK trial announced by Rhelion Life Sciences (TRUFF)?

Filament Health will supply its botanical psilocybin candidate PEX010 as the investigational drug product for PSI-PARK. According to Rhelion, UHN sponsors the study, and Filament is not the trial sponsor and is not responsible for the trial’s conduct or oversight.

What prior clinical data on psilocybin in Parkinson’s disease does Rhelion Life Sciences (TRUFF) reference?

Rhelion references an April 2025 open-label pilot study in people with mild to moderate Parkinson’s disease and mood dysfunction. According to Rhelion, that study reported no serious adverse events and sustained improvements in depression and anxiety measures, representing the first clinical data on psilocybin in any neurodegenerative disease.

How many research studies worldwide are using Rhelion’s psilocybin candidate PEX010 (OTCQB: TRUFF)?

PEX010 is supporting more than 80 academic and philanthropic research studies worldwide. According to Rhelion, this botanical, GMP-manufactured psilocybin drug candidate is supplied in standardized doses, enabling consistent composition across every dose, study, and research site using the company’s proprietary extraction and stabilization methods.

What intellectual property did Rhelion Life Sciences (TRUFF) gain from acquiring Filament Health on April 30, 2026?

Through its April 30, 2026 acquisition of Filament Health, Rhelion gained a portfolio of 76 issued patents across 15 patent families. According to Rhelion, the acquisition also consolidated its lead naturally derived psilocybin drug candidate PEX010, strengthening its psychedelic drug discovery and development platform.