Rhelion Life Sciences’ Wholly Owned Subsidiary Filament Health Signs Letter of Intent with Darmiyan, Inc. to Explore Use of FDA De Novo Authorized BrainSee(R) AI Platform in Early Alzheimer’s Disease Trial Design
- Collaboration looks to explore the use of Darmiyan’s FDA De Novo authorized BrainSee® imaging platform, authorized for predicting risk of progression to Alzheimer’s disease in patients with amnestic mild cognitive impairment, as well as Darmiyan’s core technology, the Virtual Microscope, tailored towards use in pharmaceutical clinical trials
- The goal of the collaboration is to inform the identification, selection and monitoring of the best candidates for clinical trials of PEX010, Rhelion’s patented, naturally derived psilocybin drug candidate
Toronto, Ontario–(Newsfile Corp. – August 20, 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, is pleased to announce that its wholly owned subsidiary, Filament Health Corp. (“Filament”), has entered into a non-binding letter of intent (the “LOI”) with Darmiyan, Inc. (“Darmiyan”), a San Francisco based brain technology company, to explore a collaboration combining Darmiyan’s artificial intelligence brain imaging platform with PEX010, Filament’s patented, standardized, GMP manufactured natural psilocybin drug candidate.
Darmiyan is the developer of BrainSee, which in January 2024 received marketing authorization from the U.S. Food and Drug Administration (“FDA”) through the De Novo pathway, following the granting of FDA Breakthrough Device Designation in 2021. Darmiyan is a graduate of the Y Combinator accelerator program (S17) and counts Y Combinator, Eisai Co., Ltd., the co-developer of Leqembi, and IT-Farm Corporation among its investors.
The De Novo pathway is the FDA route for novel, first-of-their-kind medical devices that carry low to moderate risk but have no legally marketed earlier device, known as a predicate, against which they can be compared. It allows a device to obtain marketing authorization on the strength of its own safety and effectiveness evidence, rather than through the far heavier premarket approval process reserved for high risk devices. A granted De Novo also creates a new device classification, establishing the predicate that subsequent products in the category must be measured against.
BrainSee combines a standard, non-contrast brain MRI with routine cognitive assessments to generate a prognostic score indicating the likelihood that a patient aged 55 or older with amnestic mild cognitive impairment (“aMCI”) will progress to Alzheimer’s dementia within five years. aMCI is an early stage of cognitive decline in which memory difficulties are measurable and noticeable to the individual and their family, but daily independence is preserved. Darmiyan’s platform takes a whole-brain, microstructural view of tissue health rather than relying on a single pathological marker, and the Company believes this holistic approach is well suited to the study of agents that may act on brain plasticity and network function.
Under the LOI, the parties intend to explore the potential of applying Darmiyan’s technology to improve the design of a possible future clinical study of PEX010 in individuals with early cognitive impairment who are at elevated risk of progression to Alzheimer’s disease. The Company believes that AI-enabled patient selection has the potential to meaningfully reduce the number of participants, the duration, and therefore the cost of clinical research in this therapeutic area, while increasing the likelihood of detecting a treatment effect if one is present. The parties also intend to explore the use of Darmiyan’s voxel-based quantitative imaging outputs as exploratory measures of biological change.
PEX010 has been selected as the investigational drug product for more than 80 academic and philanthropic research studies worldwide.
“There is a growing body of preclinical evidence that psilocybin acts as a neuroplastogen, promoting the growth and reorganization of connections between neurons,” said Shashkes (Sarit Hashkes), President of Filament Health Corp. “Alzheimer’s disease is, at its heart, a disease of lost connections. That makes it one of the most scientifically compelling and most underexplored questions in our field, and PEX010 is uniquely positioned to help answer it as a standardized, GMP manufactured, patent-protected botanical drug candidate already supplied to clinical research programs around the world. What excites me equally is the opportunity to work with the newest generation of AI tools. Trials in this indication have historically required enormous numbers of participants and many years to read out, which has kept the field closed to all but the largest companies. Technology like Darmiyan’s has the potential to change that arithmetic, and to allow a company of our size to ask serious scientific questions in early Alzheimer’s disease.”
“In our aging world, perhaps more than any other field of science or medicine, Alzheimer’s disease needs outside-the-box thinkers and innovators who are willing to challenge the existing paradigm and bring meaningful hope to patients, families, caregivers, and the broader industry,” said Padideh Kamali-Zare, PhD, Founder and Chief Executive Officer of Darmiyan. “Despite decades of investment, progress for patients has remained limited for two main reasons. First, we have not been precise enough about whom we study or how we measure meaningful change. Second, drug development has focused primarily on biomarkers, while Alzheimer’s is also a systems, network and connectivity level problem. We see strong potential for Rhelion’s drug candidate to succeed, not only because of the drug itself, but also because of the team’s mindset and its thoughtful approach to tackling this complex problem. Together, we look forward to examining whether the combination of Rhelion’s drug candidate and our technology can make Alzheimer’s research faster, smaller and more informative, ultimately accelerating the development of meaningful solutions for patients.”
“When we started in this space, this was a conversation happening at the margins,” said Todd Shapiro, Chief Executive Officer and Director of Rhelion. “Today we are signing a letter of intent with an FDA authorized artificial intelligence company out of Silicon Valley, backed by Y Combinator, to look at one of the most difficult diseases in medicine. That is the journey from underground to mainstream, and it is happening in real time. Exploring whether our drug candidate can contribute something to families facing Alzheimer’s is exactly the kind of legacy I want this team to build. With recent research, including a case report published in Frontiers pointing to the potential benefits of natural psilocybin in a case of Alzheimer’s disease, we believe this is an area that warrants serious study.”
About Darmiyan, Inc.
Darmiyan, Inc. is a San Francisco based brain health technology company incorporated in September 2016 and a graduate of Y Combinator (S17). Its lead product, BrainSee, received FDA marketing authorization through the De Novo pathway in January 2024, following FDA Breakthrough Device Designation in 2021, and is a non-invasive, AI-powered prognostic test that combines standard brain MRI with routine cognitive assessment to predict progression from amnestic mild cognitive impairment to Alzheimer’s dementia within five years. More information is available at www.darmiyan.com.
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 entering into of the LOI with Darmiyan and the negotiation, execution and terms of any definitive agreement; the scope, structure and timing of any collaboration between Filament and Darmiyan; the potential application of Darmiyan’s BrainSee platform, Virtual Microscope technology and voxel-based quantitative imaging outputs to clinical trial design, candidate selection, monitoring and exploratory measures; the design, initiation, conduct and completion of any future clinical study of PEX010 in amnestic mild cognitive impairment or early Alzheimer’s disease; the anticipated ability of AI-enabled patient selection to reduce trial size, duration and cost or to increase the likelihood of detecting a treatment effect; the therapeutic potential of psilocybin and PEX010 in cognitive impairment, neurodegenerative disease and other indications; the properties of psilocybin as a neuroplastogen; the number of academic and philanthropic research studies under supply agreement and the continued expansion of Filament’s clinical research footprint; the continued ability of Filament to manufacture and supply PEX010; and the future development, commercialization and regulatory approval of PEX010. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management as of the date hereof, are inherently subject to significant business, economic, and competitive uncertainties and contingencies.
Forward-looking information in this news release is based on certain assumptions and expected future events, namely: the ability of Filament and Darmiyan to negotiate and enter into a definitive agreement on acceptable terms; the performance by each party of its respective obligations under any such agreement; the continued availability and regulatory status of Darmiyan’s BrainSee platform; the continued ability of Filament to manufacture and supply PEX010 to research programs; the performance by counterparties of their obligations under existing supply agreements; the availability of financing on acceptable terms to fund any future clinical study; 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: the risk that no definitive agreement is entered into and that the collaboration contemplated by the LOI does not proceed; the risk that any future clinical study of PEX010 in early Alzheimer’s disease is not designed, funded, initiated or completed as anticipated; the risk that Darmiyan’s technology does not deliver the anticipated benefits in trial design, candidate selection or measurement; the risk that any study does not produce positive or clinically meaningful results; the risk that PEX010 does not demonstrate safety or efficacy in this or any other population; the risk that studies under supply agreement do not commence, enrol or progress as anticipated; delays in regulatory permitting, including clinical trial, ethics, import and export authorizations; regulatory or enforcement developments affecting the legal framework for psilocybin supply and research; adverse changes in the regulatory or political landscape affecting psychedelic research and access; and the other risk factors described in the Company’s continuous disclosure documents available under the Company’s profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned that the foregoing list is not exhaustive.
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.

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