BioCina Pty Ltd., a global end-to-end Contract Development and Manufacturing Organisation (CDMO) announced it has initiated a comprehensive CMC (Chemistry, Manufacturing, and Controls) program for the advancement of RLS-2201, a proprietary injectable formulation of Quetiapine being developed by Patrys Ltd (ASX: PAB) for the acute treatment of delirium in intensive care settings.

A reformulated RLS-2201 is being produced at BioCina's sterile manufacturing facility in Perth, under conditions designed to confirm the reproducibility and robustness of the manufacturing process. The reformulated RLS-2201 will support ICH-aligned stability studies required for regulatory submission and provide early supply for Patrys' planned first-in-human clinical activities.

"We are proud to be advancing RLS-2201 alongside a world-class CDMO partner whose deep manufacturing expertise and technical capabilities are proving instrumental in de-risking this program. Their collaborative approach to regulatory engagement gives us strong confidence as we move toward clinical trials. Together, we believe RLS-2201 has the potential to address a critical unmet need in the treatment of delirium in acute hospital settings," said Dr. Samantha South, CEO, Patrys.

The initiation of CMC activities represents a significant de-risking step for the RLS-2201 program. By validating the manufacturing process for clinical readiness at this stage, Patrys and BioCina are establishing a technically sound and regulatorily defensible pathway toward clinical trial entry, targeted for the second half of 2026. This engagement further strengthens BioCina's partnership with Patrys, reflecting BioCina's commitment to supporting clients at every stage of their product development journey.

"We are thrilled to support Patrys' journey for RLS-2201. BioCina's 50 years of experience in the development and manufacturing of sterile injectables is more than just a capability. We ensure partners like Patrys can progress to clinic with confidence, and keep the focus where it belongs - improving patient outcomes," said Dr. Tommy Broudy, CEO, BioCina.