NEW YORK, NY — December 19, 2025 — Leads & Copy — Psyence Biomedical Ltd. (Nasdaq: PBM) has received approval from the Bellberry Human Research Ethics Committee (HREC) to use PsyLabs’ psilocybin product (NPX5) in its Phase IIb clinical trial. The trial is evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in cancer patients.
The approval marks a step for Psyence BioMed as it evolves into a vertically integrated psychedelic enterprise with assets in drug and clinical development. The company reports it has a cash reserves balance of approximately USD $9.5 million.
The approval follows a review of updated clinical documentation, including the amended protocol, investigator brochure, and participant information materials. The authorization applies to all participating study sites, including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne. Psyence BioMed is planning to activate additional clinical sites to accelerate patient recruitment and advance the Phase IIb program.
Psyence BioMed CEO Jody Aufrichtig said the approval is a pivotal advancement in the company’s clinical program and a step in its long-term strategy. Aufrichtig said the company believes it is incorporating the best-in-class GMP compliant psilocybin product on the market.
The approved amendment confirms PsyLabs’ psilocybin as the investigational product used in the double-blind, randomized, low-dose comparator-controlled clinical trial. PsyLabs CEO Tony Budden said the clearance for clinical use reflects years of preparation to ensure the product meets standards for purity, repeatability, and patient safety.
The Phase IIb study will enroll approximately 87 participants and evaluate two therapeutic doses of psilocybin against a low-dose comparator, combined with structured psychotherapy. Top-line results are expected in 2026.
The company says the approval strengthens its position as one of the few companies with access to ethically sourced botanical raw materials, GMP manufacturing capabilities, and a clinical development network.
Psyence Biomedical Ltd. (Nasdaq: PBM) specializes in psychedelic-based therapeutics, and says it is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq.
PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT) to legal medical and research markets.
PsyLabs operates from an ISO 22000-certified facility audited by the British Standards Institution.
Contact Information for Psyence Biomedical Ltd.:
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Michael Kydd
Investor Relations Advisor
michael@psyencebiomed.com
Source: Psyence Biomedical Ltd.
