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Lead program: Phase II
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Research, Drug Development & Manufacturing

Psyence BiomedicalNasdaq: PBM

1 Drug Candidate

Psyence Biomedical (Nasdaq: PBM) is a clinical-stage company developing nature-derived (non-synthetic) psilocybin and ibogaine therapeutics. Spun out of Psyence Group via SPAC in early 2024, PBM is conducting a Phase IIb trial of its NPX5 botanical psilocybin product for Adjustment Disorder in cancer patients receiving palliative care — with three active sites across Australia (Perth and Melbourne). The company positions itself as the first Nasdaq-listed company focused on nature-derived psychedelic therapeutics and claims a first-mover position in psilocybin for Adjustment Disorder. It also holds worldwide exclusive licensing rights for nature-derived psilocybin in AUD and has secured GMP-compliant ibogaine HCl supply for a planned SUD programme. Note: the original CSE-listed parent (PSYG) entered an amalgamation agreement with a Ghanaian mining company in November 2025 (trading halted); the psychedelic R&D resides entirely in the separately-listed Nasdaq entity (PBM).

Development Programmes

1

NPX-5 (Nature-Derived Psilocybin)

Psilocybin
Phase II
Palliative & End-of-Life DistressAnxiety Disorders

Adjustment disorder (palliative / advanced cancer)

Programme Tracker

Palliative & End-of-Life Distress

Primary: Australia (TGA)
Phase IIActive

Phase IIb active in Australia (TGA); 87 participants; 3 sites operational (Perth, Melbourne ×2); patient dosing underway; GMP NPX-5 exported from Canada to Australia confirmed March 2026; topline results expected end of 2026

Milestones

Phase II started

Completed

Actual: Sep 1, 2024

First trial site initiated (Empax Center, Perth); patient screening started; 25mg / 10mg / 1mg (comparator) dose arms; randomised, double-blind, multi-centre

Why it matters: NPX-5 is nature-derived psilocybin (not synthetic), from GMP-certified supply via Optimi Health Corp. Psyence Biomedical is the only company running a Phase IIb with natural psilocybin in adjustment disorder — a DSM diagnosis that affects millions of cancer patients but has no approved pharmacotherapy. Australia's TGA Special Access Scheme provides a favourable regulatory environment.

Trial start

Completed

Actual: Jan 1, 2025

Multiple patients dosed across multiple sites by early 2025; three sites operational by late 2025

Why it matters: Adjustment disorder in advanced cancer patients is highly prevalent (30–40% prevalence) and underserved. Multi-site activation accelerates enrolment. Patient dosing across three Australian sites confirms operational readiness for the full trial.

Watch next: Enrollment completion and topline results (end of 2026)

regulatory-milestone

Completed

Actual: Mar 3, 2026

GMP-certified NPX-5 exported from Canada (Optimi Health) to Australia for ongoing Phase IIb trial confirmed

Why it matters: GMP supply chain for nature-derived psilocybin to an international clinical trial is a significant logistical and regulatory milestone. Psyence's exclusive supply agreement with Optimi Health and successful export validates the viability of natural psilocybin as a GMP product.

Recorded Events

Mar 3, 2026: regulatory-milestone

Jan 1, 2025: Trial start

Sep 1, 2024: Phase II started

Quick Facts

Type
Public Biotech
Ticker
Nasdaq: PBM
Lead Stage
Phase II
Website
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