Paradigm Advances Phase 3 Osteoarthritis Trial, Eyes $112M Capital Raise

Regulatory and Operational Milestones

Paradigm Biopharmaceuticals Ltd (ASX: PAR) has marked a significant step forward in its development program with the recent securing of centralised Human Research Ethics Committee (HREC) approval in Australia. This pivotal regulatory clearance enables the company to activate multiple clinical sites for its global phase 3 trial evaluating injectable Pentosan Polysulfate Sodium (iPPS) in patients suffering from moderate to severe knee osteoarthritis (OA).

The trial, registered under NCT06917404, is designed as a randomised, double-blind, placebo-controlled study involving 466 patients globally. Participants will receive 12 subcutaneous doses of iPPS over six weeks, with the primary endpoint focused on changes in average daily pain scores at Day 112. Secondary endpoints include functional assessments and imaging studies to explore potential disease-modifying effects.

Trial Execution and CRO Appointment

Operationally, Paradigm has appointed Advanced Clinical as the global Contract Research Organisation (CRO) following a rigorous selection process. This partnership is expected to leverage Advanced Clinical’s expertise in osteoarthritis trials and patient-centric execution to support the complex logistics of a multi-site global study.

Site activations are underway across approximately 10 Australian locations, including major cities such as Melbourne, Sydney, and Brisbane, with patient enrolment and dosing anticipated to commence in Q2 2025. US site start-ups are planned for the second half of the year, targeting a total of 60 centres across both countries. The company aims to reach 50% patient recruitment by the end of 2025, setting the stage for an interim analysis in mid-2026.

Financial Position and Capital Raising

Financially, Paradigm reported a cash balance of $24.56 million as of March 31, 2025, following a $6.3 million refund under the FY24 R&D Tax Incentive scheme. The company’s cash outflow for the quarter was $6.49 million, notably below the forecasted $12 million, reflecting disciplined spending during the critical trial start-up phase.

To bolster its financial runway, Paradigm has launched a Loyalty Option Offer alongside a Piggyback Option Offer, designed to reward existing shareholders and potentially raise up to $111.9 million in follow-on capital. The structure incentivises long-term holders with options exercisable at $0.65 and $1.00, expiring in 2026 and 2028 respectively, providing a strategic funding mechanism to support ongoing trial activities and future commercialisation efforts.

Investor Engagement and Future Outlook

During the quarter, Paradigm actively engaged with investors at key industry summits, including the Bell Potter Horizon Biotech Summit in Victoria and the Ignite Investor Summit in Hong Kong. Senior management, including Managing Director Paul Rennie and Dr Donna Skerrett, presented clinical progress and shared insights from prior phase 2 studies that underpin confidence in iPPS’s therapeutic potential.

Looking ahead, Paradigm is focused on meeting several critical milestones: activating clinical sites, enrolling and dosing the first patients in Australia, initiating US site operations, and progressing patient recruitment towards the interim analysis. Additionally, the company is advancing two manuscripts based on phase 2 data through peer review, which could further validate iPPS’s clinical profile upon publication.

Paradigm also continues to explore strategic partnerships or licensing agreements to extend its cash runway and accelerate the path to market. Despite a challenging macroeconomic environment for biotech, the company’s disciplined execution and investor support position it well for the next phase of clinical development.