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.