Rhelion Life Sciences Confirms Further Delivery of Filament Health’s PEX010 to Germany’s First Psilocybin Compassionate Use Program

• Filament Health has completed a further international delivery of its patented, naturally derived psilocybin drug candidate PEX010 to Germany, supporting the first compassionate use program for psilocybin in the European Union
• The Company believes the continued delivery demonstrates Filament’s ability to manufacture, release and supply pharmaceutical-grade botanical psilocybin across international regulatory jurisdictions as new legal access pathways emerge
• Rhelion intends to leverage Filament’s existing GMP manufacturing infrastructure, regulatory experience, intellectual property and international supply capabilities to pursue future commercial supply opportunities as regulated psilocybin markets and patient-access programs develop globally

Toronto, Ontario–(Newsfile Corp. – September 3, 2026) – Rhelion Life Sciences Corp. (CSE: RHEL) (FSE: 4YX0) (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 completed a further delivery of PEX010, its patented, standardized, GMP-manufactured botanical psilocybin drug candidate, to the Central Institute of Mental Health (“CIMH”) in Mannheim, Germany.

Germany’s compassionate use program for psilocybin in treatment-resistant depression is the first program of its kind in the European Union and represents an important precedent for regulated patient access to psilocybin outside of clinical trials. The program has been treating patients with PEX010 since April 2026 at two sites, CIMH in Mannheim and the OVID Clinic in Berlin, and is authorized by the German Federal Institute for Drugs and Medical Devices (“BfArM”) under Germany’s Ordinance on Medicinal Products for Compassionate Use.

Prof. Dr. med. Gerhard Gründer, Head of the Department of Molecular Neuroimaging at CIMH, serves as the responsible person for the program. Patients treated through the program are among the first in the European Union to legally receive psilocybin outside of a clinical trial.

The Company believes this latest delivery is particularly significant as governments and regulators internationally continue to evaluate pathways for controlled access to psychedelic medicines. While compassionate use programs are not equivalent to regulatory approval or broad commercialization, Rhelion believes these early access frameworks can represent important first steps in the development of future regulated markets by establishing real-world infrastructure for physician access, pharmaceutical supply, importation, distribution and supervised patient administration.

Building Infrastructure for Emerging Regulated Markets

PEX010 was manufactured in Canada by Filament’s and certified for release in the European Union by a Qualified Person within the meaning of Directive 2001/83/EC prior to delivery to Germany.

The successful delivery demonstrates several of the capabilities that the Company believes will be important as additional jurisdictions consider regulated access to psilocybin: GMP pharmaceutical manufacturing, standardized dosing, regulatory documentation, international controlled-substance logistics, import and export procedures, European pharmaceutical release requirements and reliable supply to qualified medical institutions.

Rhelion believes establishing these capabilities before broader markets develop may position Filament to participate as a pharmaceutical supplier when new research, compassionate access, special access and potentially future approved commercial pathways emerge.

The Company intends to pursue opportunities to supply PEX010 and future drug candidates into jurisdictions establishing legal and regulated psychedelic access frameworks, subject in each case to applicable regulatory approvals and requirements.

Compassionate use programs allow certain patients with serious conditions and no satisfactory approved treatment options to access investigational medicines outside of clinical trials under strict medical supervision and regulatory oversight.

Treatment-resistant depression affects a substantial proportion of individuals diagnosed with major depressive disorder and remains one of the most challenging conditions in psychiatry to treat.

“We are very grateful that we can now make this form of therapy available to our patients outside of clinical trials. There is an enormous need for it,” said Prof. Dr. med. Gerhard Gründer, Central Institute of Mental Health.

“We believe expanding access is one of the first steps toward expanding markets,” said Todd Shapiro, Chief Executive Officer and Director of Rhelion. “Germany has created an important regulatory precedent. More importantly for Rhelion, our team isn’t waiting for potential future markets to develop before building the infrastructure required to serve them. Filament is already manufacturing pharmaceutical-grade botanical psilocybin in Canada, navigating international regulatory requirements and delivering PEX010 into Europe for actual patient use.”

“Our strategy is to position Rhelion as a trusted pharmaceutical grade supplier as legal access to psilocybin expands globally,” continued Shapiro. “Every responsible new pathway, whether for research, compassionate use, special access or ultimately broader regulated medical use – potentially creates another market requiring standardized, GMP-manufactured drug products. Filament has spent years developing the intellectual property, manufacturing capabilities, regulatory experience and global supply relationships necessary to participate in those markets. As governments open responsible pathways, we intend to be ready to supply them.”

A Growing Global Supply Platform

PEX010, Filament Health’s botanical psilocybin drug candidate, underscores Filament’s position as a supplier of pharmaceutical-grade naturally derived psilocybin. Filament has supported more than 80 academic and philanthropic research studies worldwide and has supplied PEX010 across multiple international regulatory and research pathways.

The Company’s growing international supply footprint provides Rhelion with an opportunity to build relationships with investigators, physicians, institutions and regulators in markets evaluating the future medical use of psychedelic drug candidates.

Rhelion believes that the potential commercial opportunity for pharmaceutical-grade psilocybin extends beyond any single clinical indication or jurisdiction. If additional countries establish regulated access frameworks, each may require compliant pharmaceutical manufacturing, validated quality systems, standardized dosing, controlled-substance import and export capabilities and dependable drug supply. Filament has developed infrastructure intended to address these requirements.

PEX010 is currently available in standardized doses of 1 mg, 5 mg and 25 mg, with a 0.5 mg dose planned. PEX010 is produced using Filament’s proprietary and patented extraction, purification and stabilization methods designed to provide consistent composition across doses and sites.

On April 30, 2026, the Company completed its previously announced acquisition of Filament Health Corp., including its portfolio of 77 issued patents across 13 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 psychedelic drug candidates, including its patented PEX010 botanical psilocybin drug candidate, while supporting clinical research and regulated patient-access programs with institutions around the world.

The Company’s strategy includes leveraging Filament’s intellectual property portfolio, GMP manufacturing capabilities, regulatory infrastructure and international supply experience to pursue drug development, licensing and pharmaceutical supply opportunities as regulated psychedelic medicine markets continue to evolve.

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, objectives and opportunities, 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 administration of PEX010 to patients under the German compassionate use program; the continuation, renewal or expansion of the German compassionate use program; the establishment or expansion of compassionate use, special access, research, medical or comparable regulated access pathways for psilocybin in other jurisdictions; the potential for compassionate use, special access and other early access frameworks to contribute to the development of broader regulated markets for psilocybin and other psychedelic drug candidates; the continued ability of Filament to manufacture, release, export and supply PEX010 into Germany and other jurisdictions; the Company’s ability to leverage Filament’s GMP manufacturing infrastructure, regulatory experience, intellectual property and international supply capabilities; the Company’s intention and ability to pursue pharmaceutical supply, licensing and other commercial opportunities as regulated psychedelic markets and patient-access pathways develop; the potential for additional jurisdictions and regulated access pathways to create demand for standardized, GMP-manufactured psilocybin drug products; the Company’s ability to participate as a supplier in such existing and emerging markets; the potential expansion of Filament’s international supply footprint and relationships with investigators, physicians, institutions and regulators; the potential for expanded international supply, patient access and market development to result in future commercial opportunities or revenues for the Company; the number of academic and philanthropic research studies supplied with PEX010 and the continued expansion of Filament’s clinical research and compassionate access footprint; the therapeutic potential of psilocybin and PEX010 in treatment-resistant depression and other indications; the availability of the standardized dosing range of 1, 5 and 25 mg of PEX010 and the planned availability of a 0.5 mg dose; the Company’s ability to leverage the assets, clinical infrastructure, intellectual property and capabilities acquired through its completed acquisition of Filament Health; there can be no assurance that additional jurisdictions will establish regulated psilocybin access programs, that existing programs will expand, or that such developments will result in material revenues for the Company and the future development, commercialization and regulatory approval of PEX010 and other drug candidates.

Forward-looking information in this news release is based on certain assumptions and expected future events, namely: the continued ability of Filament and Psilo Scientific Ltd. to manufacture, release and supply PEX010 in accordance with applicable pharmaceutical, quality and regulatory requirements; the continued availability of Qualified Person certification services in the European Union; the performance by the Central Institute of Mental Health, the Qualified Person service provider and the Company of their respective obligations in connection with the supply of PEX010; the continued authorization and operation of the compassionate use program by BfArM; the ability to obtain and maintain required regulatory permits and approvals, including controlled-substance import and export authorizations; the continued development of regulated pathways for psychedelic medicines in certain jurisdictions; the establishment or expansion of compassionate use, special access or comparable regulated access frameworks in additional jurisdictions; the Company’s ability to participate as a pharmaceutical supplier if and when such pathways and markets develop; the Company’s ability to maintain and leverage Filament’s GMP manufacturing capabilities, intellectual property portfolio, regulatory infrastructure and international supply experience; the existence and development of demand for standardized pharmaceutical-grade psilocybin drug products; the Company’s ability to identify and pursue pharmaceutical supply, licensing and other commercial opportunities; and general business, market, regulatory 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, supply and patient access; the risk that the German compassionate use program is not renewed, is suspended, modified or does not proceed as anticipated; the risk that patients are not treated or do not experience clinical benefit; the risk that supply into Germany or other jurisdictions does not continue or materialize as expected; delays or failures in obtaining or maintaining regulatory permits and approvals, including import and export authorizations; the risk that comparable access pathways are not established or expanded in other jurisdictions; the risk that compassionate use, special access or other early access pathways do not develop into broader regulated or commercial markets; the risk that emerging regulated markets do not develop on the timelines or to the extent anticipated by the Company; the risk that demand for pharmaceutical-grade psilocybin drug products does not develop as anticipated; the risk that the Company is unable to successfully participate or compete as a supplier in existing or emerging markets; the risk that expanded patient access, international supply activities or new regulated markets do not result in material commercial opportunities or revenues for the Company; manufacturing, quality-control, supply-chain and regulatory risks associated with producing and supplying PEX010; risks associated with the Company’s ability to protect and commercialize its intellectual property; adverse changes in the regulatory or political landscape affecting psychedelic research, drug development and patient 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/312780