Psyence Biomedical Ltd.

PSYENCE BIOMEDICAL LTD. is a company that engages in clinical research, specifically managing a Phase IIb Study through its wholly-owned subsidiary, Psyence Australia. On May 21, 2025, Psyence Australia entered into a Master Services Agreement (MSA) with Southern Star Research, which will act as the Contract Research Organization (CRO) for the Company's registrational Phase IIb Study. Southern Star Research will provide a range of CRO services, including Trial Management & Oversight, which covers clinical monitoring, site initiation, site management, and close-out activities. They will also handle Project Management, involving the development and maintenance of a detailed project plan, coordination of teams, and status reporting. Data Management & Biostatistics services include designing, building, and maintaining the electronic data capture (EDC) system, data cleaning, database lock, and generating statistical reports. Regulatory & Ethics Support involves preparing submissions to the Therapeutic Goods Administration (TGA) in Australia and local ethics committees, as well as managing regulatory correspondence. Pharmacovigilance & Safety Oversight includes collecting, processing, and reporting adverse events. Patient Recruitment & Retention assistance will focus on site selection, patient screening, and retention programs to enroll the target 87 participants in the double-blind, placebo-controlled study. Finally, Transitional Handover will coordinate with the Company's prior CRO, iNGEN, for a seamless transition. The Company will pay Southern Star Research aggregate fees, structured as an upfront deposit (a percentage of total project costs) and monthly invoices for services delivered, plus reimbursement for out-of-pocket costs.