Patrys Issues 110M Shares to Acquire Reliis and Advance $2B Delirium Drug

Strategic Acquisition to Address Delirium

Patrys Limited (ASX, PAB) has announced the acquisition of Reliis, a clinical-stage biopharmaceutical company focused on developing an innovative injectable formulation of quetiapine, branded as AQS, for the treatment of delirium. This acquisition is a strategic pivot for Patrys, expanding its footprint into a fast-to-market opportunity addressing a significant unmet medical need in acute neurocognitive care.

Delirium affects millions globally, particularly in intensive care units (ICU), palliative care, and aged care settings. Current treatment options are limited, with no approved drugs specifically indicated for delirium and widespread reliance on off-label antipsychotics and sedatives that carry safety and efficacy concerns. AQS offers a novel intravenous and subcutaneous formulation designed to provide rapid onset of action; within one minute compared to the two-hour delay of oral quetiapine; improving patient outcomes and safety for both patients and healthcare staff.

Innovative Reformulation and Regulatory Pathway

Reliis’s approach leverages the FDA’s 505(b)(2) regulatory pathway, which allows reformulated drugs to gain approval more quickly and at significantly lower cost than traditional new drug development. This pathway capitalises on existing safety and efficacy data for oral quetiapine, enabling Patrys to fast-track clinical development with bridging studies and targeted Phase 1 and Phase 2/3 trials planned between 2026 and 2028.

The acquisition consideration includes the issuance of 110 million shares, 70 million performance rights tied to clinical milestones, and additional facilitation shares, reflecting Patrys’s commitment to integrating Reliis’s assets and expertise. Notably, Reliis co-founders Leanne Kite and Dino Cercarelli have joined the Patrys board, bringing deep clinical, governance, and capital markets experience to support the development program.

Market Potential and Competitive Edge

The global market for delirium treatment is estimated at over US$2 billion annually, with substantial segments in ICU, palliative, and aged care. AQS’s injectable formulation addresses key limitations of current off-label treatments by offering 100% bioavailability, customizable dosing, and a safer side effect profile, including reduced sedation and cardiac risks.

Patrys highlights that AQS’s rapid onset and improved safety profile could reduce ICU stays and hospital costs, making it attractive to healthcare providers and payers. The company is actively exploring strategic partnerships with established hospital-focused pharmaceutical companies to support late-stage clinical trials and commercialisation.

Intellectual Property and Development Milestones

Reliis holds provisional patents covering the new formulation and method of use for delirium, with applications entered into major jurisdictions including the US, EU, UK, and Australia. This intellectual property provides a strong foundation for market exclusivity as Patrys advances clinical development.

Key upcoming milestones include completion of clinical manufacturing batches, ethics approvals, initiation and completion of Phase 0 and Phase 1 trials, and an IND submission targeted for early 2028. These steps will be critical to validating AQS’s safety and efficacy in ICU patients and progressing toward pivotal Phase 2/3 trials.

Overall, Patrys’s acquisition of Reliis and its injectable quetiapine formulation represents a compelling opportunity to transform delirium treatment with a differentiated product backed by a clear regulatory and commercial strategy.