New York, New York–(Newsfile Corp. – April 8, 2025) – Psyence BioMed (NASDAQ: PBM) (“Psyence BioMed” or the “Company”) today announced the signing of a Letter of Intent (LOI) with Southern Star Research Pty Ltd, a premier Australian contract research organization (CRO). This collaboration will accelerate Psyence BioMed’s ongoing Phase IIb psilocybin clinical trial in Australia, which focuses on adjustment disorder in patients diagnosed with cancer.
Adjustment disorder ranks as the seventh most frequently diagnosed psychiatric condition globally, affecting millions of people who currently have no FDA-approved pharmaceutical treatment.
The engagement of a new CRO represents a pivotal step in optimizing Psyence BioMed’s clinical trial, enabling collaboration with a broader national oncology and mental health network to accelerate the Phase II clinical trial timeline. Southern Star Research’s scale and capabilities will support the next phase of the Company’s clinical development plan. Psyence BioMed thanks iNGENū CRO for their contribution to the protocol design, ethics approval and site activation. To ensure continuity and operational efficiency, Psyence BioMed is coordinating a seamless handover of trial management responsibilities to Southern Star Research as it moves forward with its clinical programs.
“Southern Star Research’s state-of-the-art operations, with its advanced infrastructure, national network within Oncology and Mental health, as well as in-depth knowledge of the Australian clinical trial environment will enhance patient recruitment and support efficient trial execution,” said Dr. Neil Maresky, CEO of Psyence BioMed. “Their expertise and dedication to clinical excellence make them a strong partner in our mission to develop innovative therapies that address the urgent mental health needs of patients with adjustment disorder.”
Dr David Lloyd, Managing Director and Co-Founder of Southern Star Research, expressed enthusiasm for the collaboration, stating: “We are excited to collaborate with Psyence BioMed on the expansion of their Phase IIb clinical trial. This partnership represents a significant step in our long-term commitment to advancing novel psychedelic-assisted therapies for mental health conditions such as adjustment disorder, an area with an enormous unmet need. Our talented team is dedicated to supporting the development of pioneering treatments, and we look forward to contributing to the success of this important clinical trial and many more in the future.”
Psyence BioMed senior leadership will discuss the new agreement during the Company’s corporate webinar on Thursday, April 10, 2025, at 12:00 PM EST.
To register, please visit: https://psyencebiomed.com/corporate-webinar_april2025/
About Southern Star Research Pty Ltd
Southern Star Research Pty Ltd is an Australian full-service CRO specializing in providing clinical trial services for biotechnology and pharmaceutical companies. With a strong focus on quality and partnership. Southern Star Research is dedicated to advancing clinical research and helping bring innovative therapies to patients.
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-based psychedelic medicine to be listed on Nasdaq. Psyence is dedicated to addressing unmet mental health needs, particularly in palliative care. The name ‘Psyence’ merges ‘psychedelics’ and ‘science,’ reflecting the company’s commitment 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.
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
Michael Kydd
Investor Relations Advisor michael@psyencebiomed.com