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.

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