Paradigm Biopharmaceuticals Ltd (ASX:PAR) Announces Phase 3 Trial Launch and Financial Update
Operational Update
Paradigm Biopharmaceuticals Ltd (ASX:PAR) has secured centralised HREC approval in Australia, enabling the launch of a multi-site Phase 3 trial for injectable Pentosan Polysulfate Sodium (iPPS) in knee osteoarthritis. The first patient dosing is on track for Q2 CY2025. Advanced Clinical has been appointed as the global CRO to support the trial’s execution.
Financial Highlights
As of 31 March 2025, Paradigm holds a cash balance of $24.56 million, with cash spending for the March quarter at $6.49 million, $5.51 million below the forecast. The company received a $6.3 million refund under the FY24 R&D Tax Incentive scheme, enhancing its financial runway.
Shareholder Programs
Paradigm launched its Loyalty and Piggyback Option Offers during the March quarter, rewarding shareholders with options and offering potential follow-on capital raises of over $110 million.
Executive Comments
Managing Director Paul Rennie stated, “This quarter for Paradigm we have successfully transitioned from regulatory clearance into trial execution. Despite a challenging macroeconomic backdrop for biotech, with funding uncertainty in global research institutions, shifting sentiment in Washington, and structural changes within the FDA, we are pleased with our ability to maintain momentum. We now enter the June quarter with clear line of sight to multiple operational milestones, including site activation, first patient enrolment, and dosing in Australia. As we move forward, we are energised by the robust data we’ve consistently demonstrated across previous Phase 2 trials and the real-world evidence base built through hundreds of patient experiences with iPPS. Our team remains focused on disciplined execution and maintaining the trust of our shareholders, whose continued belief in the therapeutic potential of iPPS is both acknowledged and deeply appreciated.”
Motley Fool contributor Aaron Shaw has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
This article was generated using GPT-4o mini, a Large Language Model (LLM), to generate summaries of investing news. While AI is generating the content, we know better than to blindly trust our future robot overlords, and every article is edited and fact-checked by an editor holding the appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content of everything published by The Capital Club.
