Psyence BioMed Announces Export of GMP-Manufactured Natural Psilocybin (NPX-5) to Australia for Ongoing Phase IIb Clinical Trial

NEW YORK, March 03, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced the successful export of fully GMP-compliant manufactured psilocybin product NPX-5 (1mg and 5mg capsules) to Australia. The product was manufactured at the Psyence Labs Ltd. (“PsyLabs”) GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development.

The shipment represents an operational achievement for both Psyence BioMed and PsyLabs, reinforcing their shared commitment to establishing a regulated global supply chain for nature-derived psychedelic therapeutics.

The exported NPX-5 product will now be used in Psyence BioMed’s ongoing Phase IIb clinical trial in Australia – a double-blind, randomized, low-dose comparator-controlled, multi-center study evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care context.

The trial is enrolling 87 participants across multiple Australian sites, including Melbourne and Perth. Psyence BioMed is currently the only company conducting a Phase IIb clinical trial using natural psilocybin to study Adjustment Disorder in a palliative oncology population. Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5.

“This export demonstrates more than regulatory clearance – it validates the operational readiness of our vertically integrated model,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed. “The successful manufacture and export of GMP-compliant natural psilocybin at this stage of clinical development demonstrates that we are not simply participating in this sector – we are helping define its standards. Operational discipline, supply control, and product excellence are foundational to our platform.”

Clinical Significance

The Phase IIb trial focuses on Adjustment Disorder, an excessive and sometimes debilitating psychological response to a significant life stressor – in this case, advanced cancer. The study aims to evaluate the efficacy, safety, and durability of a psycho-therapeutic approach utilizing nature-derived psilocybin to reduce anxiety and depressive symptoms in this vulnerable patient population.

As a regulated, nature-derived formulation rather than a synthetic analogue, Psyence BioMed’s approach represents a differentiated pathway within psychedelic therapeutics – integrating pharmaceutical-grade manufacturing with clinical rigor in palliative mental health care.

“Our team executed this export with efficiency and strict adherence to GMP standards because patient safety is paramount,” said Tony Budden, CEO of PsyLabs. “Every capsule supplied to this trial has been produced under rigorous quality controls to help ensure a safe, consistent, and reliable experience for patients participating in this important study.”

Manufacturing & Global Supply Chain Leadership

PsyLabs operates a GMP-compliant production and analytical facility capable of manufacturing pharmaceutical-grade natural psilocybin and ethically sourced ibogaine at scale. The successful export of NPX-5 capsules to Australia demonstrates:

• Full GMP compliance.
• International regulatory authorization for shipment.
• Operational global supply chain capability.
• Vertical integration across cultivation, extraction, manufacturing, and quality assurance.

This development further strengthens the strategic alignment between Psyence BioMed and PsyLabs as they build a scalable, compliant, and resilient global infrastructure for nature-derived psychedelic medicines. PsyLabs holds a 49.98% equity stake in the Company and Certain members of the Company’s management are affiliates of PsyLabs and have financial interests in PsyLabs.

“As the psychedelic sector matures, infrastructure and supply certainty will differentiate sustainable pharmaceutical platforms,” added Aufrichtig. “This shipment marks meaningful progress in advancing our strategy and demonstrates our ongoing efforts to operate in a disciplined and globally coordinated manner.”