Medibio Limited advised that Dr. Thomas Young will transition from his role as part-time Chief Executive Officer to a Non-Executive Director position effective 6 October 2023. Dr. Young was appointed to the role of CEO during September 2022 in a limited capacity. During his tenure, he oversaw the completion of Phase 1 trials for Medibio's Sleep Signal Analysis for Current Major Depressive Episode study (SAMDE), followed by the commencement of the Phase 2 trial.

The Company's SAMDE study has been designed to build and train Medibio's innovative algorithm (MEB-001) to assist in the screening for a current major depressive episode (cMDE) in test subjects. Dr. Young's management of day-to-day operations has played a central role in the success of the SAMDE study to-date, and as a Non-Executive Director, Dr. Young will continue to guide the Company through regulatory approval from the US Food and Drug Administration (FDA). As previously advised, Medibio is pursuing final clinical validation of its technology via the De Novo regulatory pathway.

Medibio expects to schedule the meeting with the FDA in First Quarter CY2024, which will provide a clear timeframe on the regulatory approval process. The Board and management look forward to leveraging Mr. Young's extensive experience to progress the commercialisation pathway. Dr. Young's transition to a Board role is in line with his stated intention to step back from executive duties once the early phases of the trial process were successfully completed.

Following Dr. Young's transition, CEO duties will be shared by the Company's existing management team. The shift has also allowed Medibio to commence an executive search for a full-time CEO that can lead the Company through the next phase of its stated growth trajectory. A number of potential candidates have been earmarked for the role, each with exceptional experience in the US healthcare and sleep sectors.

Additional updates will be provided as appointments are made in the coming months.