Rua partners to supply medicinal MDMA in New Zealand

Tairawhiti, New Zealand and Toronto, Canada – Rua Bioscience Limited (NZX: RUA) and PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) announce that Rua and PharmAla Biotech Inc., a subsidiary of PharmAla, have signed a distribution and licence agreement. Under the agreement, Rua will import, distribute and sell PharmAla’s pharmaceutical-grade LaNeo MDMA in New Zealand. MDMA is a psychoactive compound best known for its recreational use as “ecstasy”. In a medical setting, pharmaceutical-grade MDMA is administered in a highly controlled environment and is being used as an adjunct to psychotherapy for conditions including post-traumatic stress disorder (PTSD). The agreement follows Medsafe’s approval, on 4 September 2026, of two psychiatrists to prescribe pharmaceutical-grade MDMA for PTSD. This represents an important development in New Zealand’s emerging psychedelic-assisted therapy sector and allows these authorised psychiatrists to prescribe MDMA in accordance with their Medsafe approval. Rua will work to supply LaNeo MDMA to authorised prescribers in New Zealand. The first shipment will be supplied on a consignment basis, enabling Rua to enter the market with minimal upfront capital. A natural extension of Rua’s business Rua has built its business on the safe, compliant supply of controlled medicines. Its licensing, quality systems, regulatory expertise and prescriber relationships in medical cannabis apply directly to this new category. The agreement adds a second regulated medicine to Rua’s portfolio and opens a new revenue opportunity without significant additional investment, consistent with Rua’s capital-light strategy. A GMP partner with an established supply record PharmAla is one of the first companies in the world to manufacture GMP-grade MDMA. It supplies clinical trials and authorised prescribers internationally, including in Australia, where authorised psychiatrists have prescribed MDMA since 2023. The rise of psychedelic medicine Psychedelic medicine is moving from the margins into mainstream clinical practice. In 2023, Australia became the first country to allow authorised psychiatrists to prescribe MDMA and psilocybin. New Zealand followed with its first approval to prescribe psilocybin for treatment-resistant depression in 2025, and now MDMA for PTSD. For people whose conditions have not responded to conventional treatment, these medicines offer a carefully controlled new option, delivered under strict clinical supervision. Rua has a long-standing interest in this field. It supports Tū Wairua, an Indigenous-led clinical study at Rangiwaho Marae in Te Tairāwhiti that explores the potential of psilocybin-containing fungi to help people overcome methamphetamine addiction. That work reflects Rua’s belief that well-researched, culturally grounded and properly regulated medicines can bring meaningful benefit to whanau and communities. Paul Naske, Chief Executive Officer of Rua Bioscience, said: “Medicinal cannabis taught us that safe, regulated access to new medicines starts with small, careful steps. Medsafe’s decision on MDMA is one of those steps, and we’re proud to help make it real for patients. This agreement builds on what Rua already does well, adds a new product category to our business, and positions us early in a field we expect to grow as the evidence and the regulatory framework continue to develop.” Nicholas Kadysh, Chief Executive Officer of PharmAla Biotech, said: “Medsafe’s decision gives New Zealand psychiatrists a path to treat PTSD with MDMA. Those clinicians need a reliable, GMP-grade supply. Rua has the licences, quality systems and prescriber relationships to deliver it from day one, and shares our regulatory-first approach. We are pleased to partner with them.” Looking ahead Rua will now work with PharmAla and Medsafe to complete the regulatory and quality steps before the first shipment. Patient numbers will be modest at first, but both companies see this as an important first step in a broader shift in how Aotearoa approaches mental health treatment. About PharmAla PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) is a biotechnology company focused on the research, development and manufacturing of MDxx class molecules, including MDMA. PharmAla manufactures GMP-grade LaNeo MDMA for clinical trials and authorised prescribers, and develops novel MDxx class drugs, including its lead candidate ALA-002. PharmAla is a “regulatory first” organization. ENDS The person who authorised this announcement: Paul Naske Chief Executive Officer paul.naske@ruabio.com +64 21 445154