Mr. Nicholas Kadysh reports

RUA BIOSCIENCE AND PHARMALA BIOTECH PARTNER TO SUPPLY MEDICINAL MDMA IN NEW ZEALAND

Rua Bioscience Ltd. Pharmala Biotech Inc., a subsidiary of Pharmala Biotech Holdings Inc., have signed a distribution and licence agreement. Under the agreement, Rua will import, distribute and sell Pharmala's pharmaceutical-grade LaNeo MDMA (3,4-methylenedioxymethamphetamine) in New Zealand.

The agreement follows Medsafe's approval, on Sept. 4, 2026, of two psychiatrists to prescribe pharmaceutical-grade MDMA for posttraumatic stress disorder (PTSD). This makes New Zealand only the second country, after Australia, to allow authorized psychiatrists to prescribe MDMA. Rua will supply Pharmala's 40-milligram LaNeo MDMA capsules, manufactured to good manufacturing practice (GMP) standards, to authorized prescribers in New Zealand. The first shipment will be supplied on a consignment basis so Rua can 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 authorized prescribers internationally, including in Australia, where authorized 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 authorized 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.

Paul Naske, chief executive officer of Rua Bioscience, said: "Medical 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 remaining 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 New Zealand approaches mental health treatment.

Termination of prior New Zealand distribution agreement

Pharmala also announces that, on Sept. 1, 2026, Pharmala Biotech Inc. and JC Logistics Ltd. (trading as Veridion Group) signed a termination and mutual release agreement. It ends, by mutual consent, the exclusive New Zealand distribution and licence agreement between them dated Sept. 21, 2025, which Pharmala announced on Sept. 25, 2025. Veridion held no Pharmala inventory, purchase orders or regulatory registrations, and no amounts are payable by either party in connection with the termination. The termination allowed Pharmala to appoint Rua as its New Zealand distributor.

About Pharmala Biotech Holdings Inc.

Pharmala Biotech Holdings 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 authorized prescribers and develops novel MDXX-class drugs, including its lead candidate, ALA-002. Pharmala is a regulatory-first organization.

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