Psyence BioMed Announces Approval for Use of PsyLabs' Psilocybin Product in Phase IIb Clinical Trial
NEW YORK, Dec. 19, 2025 (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 that the Bellberry Human Research Ethics Committee (HREC) has formally approved the use of PsyLabs' psilocybin product (NPX5) in the Company's ongoing Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer.
This approval highlights the Company's distinct evolution toward becoming one of the few vertically integrated psychedelic enterprises with multiple assets across drug and clinical development. With an investment in Psylabs, significant clinical assets and a strong cash reserves balance of approximately USD $9.5 million, the Company is now positioned as one of the most differentiated companies in the emerging global psychedelics sector with the cash balance to execute on its strategy.
Approval was granted following review of updated clinical documentation, including the amended protocol, investigator brochure, and participant information materials, all reflecting the transition to PsyLabs' psilocybin formulation. The authorization applies to all participating study sites, including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne. The Company has also begun planning the activation of additional clinical sites to further accelerate patient recruitment and advance the Phase IIb program.
"We are extremely pleased that PsyLabs' nature-derived psilocybin product has now been formally approved for use in our Phase IIb study," said Jody Aufrichtig, CEO of Psyence BioMed. "This is a pivotal advancement in our clinical program and a defining step in our long-term strategy. By incorporating what we believe is the best-in-class GMP compliant psilocybin product on the market – developed entirely within our vertically integrated structure – we are reinforcing supply-chain control, manufacturing excellence, and scalable production capacity that will drive future commercial success."
The approved amendment confirms PsyLabs' psilocybin as the investigational product used in the double-blind, randomized, low-dose comparator-controlled clinical trial. This positions PsyLabs as a key contributor to Psyence BioMed's clinical-stage infrastructure, reinforcing the Company's ability to oversee the development pathway from ethical raw material sourcing through formulation, clinical evaluation, and eventual commercialisation.
"Having our psilocybin formulation cleared for clinical use is a transformative moment for PsyLabs," said Tony Budden, CEO of PsyLabs. "It reflects years of scientific, regulatory, and manufacturing preparation to ensure our product meets the highest standards for purity, repeatability, and patient safety. We are proud to support Psyence BioMed's mission to bring safe, nature-derived psychedelic therapies into regulated medicine."
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. With multiple sites activated and recruitment underway, the study remains on track to deliver top-line results in 2026.
This approval further strengthens Psyence BioMed's competitive positioning as one of the few companies globally with access to ethically sourced botanical raw materials, GMP manufacturing capabilities, and a fully aligned clinical development network.
About Psyence BioMed
Psyence Biomedical Ltd. (NASDAQ:PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. 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. We are dedicated to addressing unmet mental health needs, particularly in palliative care. The company is committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders.
Learn more at www.psyencebiomed.com and on LinkedIn.
About PsyLabs
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. The company has successfully exported psilocybin products to Canada, the UK, Portugal, and Slovenia, and supplies purified extracts to its UK-based CMO partner.
PsyLabs operates from an ISO 22000-certified facility audited by the British Standards Institution, ensuring the highest standards of safety and traceability. With a focus on natural compound purification, regulatory support, and global distribution, PsyLabs is expanding its product pipeline to include ibogaine and other next-generation psychedelics.
Contact Information for Psyence Biomedical Ltd.
Email: [email protected]
Media Inquiries: [email protected]
General Information: [email protected]
Phone: +1 416-477-1708
Investor Contact:
Michael Kydd
Investor Relations Advisor
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Forward Looking Statements
This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations, and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the progress of the Phase IIb clinical trial, the expansion of the Company's manufacturing capabilities, the future commercial success of the Company's vertically integrated structure, and the estimated date of delivery of top-line results. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule, the Company will retain all such regulatory and other consents required to complete the trial , and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq's continued listing requirements. There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
These risks and uncertainties include, among others: (i) delays in the execution of the Phase IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence BioMed due to a variety of factors, including the recent share consolidation, changes in the competitive and highly regulated industries in which Psyence BioMed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence BioMed's business and changes in Psyence BioMed's capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the Company's final prospectus (File No. 333-289285) filed with the Securities and Exchange Commission (the "SEC") on November 3, 2025 and other documents filed by Psyence BioMed from time to time with the SEC.
These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence BioMed does not intend to update these forward-looking statements.
The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company's performance and operations.
