How Patrys’ New Injectable Antipsychotic Could Transform $2B Delirium Market
Patrys Limited has expanded its clinical pipeline by acquiring Reliis Pty Ltd, gaining a proprietary injectable formulation of Quetiapine aimed at the large and underserved delirium market. This strategic move balances Patrys’ portfolio with a near-term pharmaceutical asset alongside its biologics program.
- Acquisition of Reliis adds injectable Quetiapine (RLS-2201) targeting delirium
- Addresses a US$2 billion+ global market with no approved acute delirium treatments
- Near-term clinical milestones include Phase 0 and Phase I trials planned
- Deal includes issuing 110 million shares and 70 million performance rights
- Two Reliis executives nominated to join Patrys board post-acquisition
Strategic Expansion into Delirium Treatment
Patrys Limited (ASX – PAB), a company traditionally focused on developing biologic therapies, has taken a significant step to diversify its pipeline by acquiring Reliis Pty Ltd. Reliis is advancing RLS-2201, a proprietary injectable formulation of Quetiapine designed to treat delirium in intensive care and aged care settings. This acquisition opens a pathway into a substantial US$2 billion global market that currently lacks approved acute-care treatments.
Delirium is a serious neurocognitive disorder affecting over 500 million people worldwide annually, particularly prevalent in ICU patients, palliative care, and aged care residents. The condition leads to longer hospital stays, increased complications, and higher mortality rates. Despite its prevalence, treatment options remain limited, with oral antipsychotics used off-label and often suboptimal in critical care environments.
A Near-Term, De-Risked Asset
RLS-2201’s injectable formulation aims to overcome the limitations of oral therapies by providing rapid, predictable onset and precise dosing suitable for acute care. The reformulation leverages the known safety profile of Quetiapine while benefiting from an expanding intellectual property portfolio. Patrys plans to pursue accelerated regulatory pathways, including the FDA’s 505(b)(2) and EMA’s abridged approval routes, which are commonly used for reformulated drugs and could shorten development timelines.
In the next 12 months, Patrys intends to finalize manufacturing with BioCina, engage regulators to confirm development pathways, and conduct a Phase 0 exploratory study to characterize pharmacokinetics in healthy volunteers. These steps are designed to de-risk the clinical program and set the stage for a Phase I safety trial in ICU patients.
Balancing Innovation and Near-Term Catalysts
The acquisition strategically balances Patrys’ portfolio by pairing its longer-term biologics program, including the PAT-DX3 antibody candidate, with a lower-risk pharmaceutical asset that offers near-term clinical catalysts. This dual-platform approach enhances the company’s risk-reward profile and broadens opportunities for value creation.
Financially, the acquisition consideration includes issuing 110 million shares and 70 million performance rights to Reliis shareholders, subject to shareholder approval. Additionally, 25 million shares will satisfy convertible notes, and further shares will be issued to advisors. Two Reliis co-founders, Leanne Kite and Dino Cercarelli, are nominated to join the Patrys board, bringing expertise in finance, governance, and clinical trial operations.
Market Potential and Next Steps
Reformulated hospital therapeutics have demonstrated strong commercial outcomes, with precedent deals reaching hundreds of millions to over a billion dollars. RLS-2201’s positioning in a large, underserved market with strong clinician demand suggests significant upside potential for Patrys and its shareholders.
Patrys is targeting a shareholder meeting in mid-January 2026 to approve the acquisition and related securities issuance. Investors will be watching closely for regulatory feedback, clinical trial progress, and integration of the new asset into Patrys’ broader strategy.
Bottom Line?
Patrys’ acquisition of Reliis positions it to rapidly enter a large, unmet market with a de-risked asset, setting the stage for near-term clinical milestones and potential value uplift.
Questions in the middle?
- Will regulatory agencies confirm eligibility for accelerated approval pathways for RLS-2201?
- How will Patrys balance resource allocation between its biologics program and the new pharmaceutical asset?
- What commercial partnerships or licensing deals might Patrys pursue to maximise RLS-2201’s market potential?