Recruitment Pace and Funding Key as Paradigm Advances Phase 3 Knee OA Trial

Global Trial Expansion and Recruitment Momentum

Paradigm Biopharmaceuticals has reported steady advancement in its pivotal Phase 3 clinical trial (PARA_OA_012) investigating injectable pentosan polysulfate sodium (iPPS) for knee osteoarthritis pain. The December quarter saw the majority of clinical sites across Australia and the United States become active and recruiting, with patient screening and enrolment gaining traction.

Significantly, Paradigm is broadening its international footprint with new clinical sites in Hong Kong and Moldova expected to commence screening shortly. These additions aim to enhance recruitment efficiency and geographic diversity, leveraging experienced investigators and established infrastructure. The Hong Kong site aligns strategically with the region’s new regulatory pathway, potentially smoothing future registration and commercialisation efforts.

Scientific Validation Strengthens Program

Following the quarter’s end, Paradigm achieved a notable milestone with the publication of its Phase 2 PARA_OA_008 biomarker study in a respected international peer-reviewed journal. This study demonstrated favourable biological effects of iPPS on markers linked to cartilage degradation, inflammation, and pain signalling within osteoarthritic joints, providing mechanistic support for the ongoing Phase 3 trial.

Additional manuscripts are underway, including imaging-based structural findings from the Phase 2 study and translational research in canine osteoarthritis conducted with the University of Melbourne. These publications reinforce the scientific foundation of Paradigm’s clinical program and are expected to bolster regulatory and commercial engagement.

Financial Position and Outlook

Paradigm closed the quarter with a cash balance of approximately A$14.66 million, supplemented by an undrawn convertible note facility of A$22.41 million. Net cash used in operating activities was A$12.61 million, primarily directed towards clinical trial execution including site activations, patient recruitment, and manufacturing.

The company forecasts cash outflows of A$12–15 million for the March quarter, reflecting an operational ramp-up across multiple sites. An anticipated R&D tax incentive rebate of around A$6.2 million will provide a meaningful non-dilutive funding boost. Paradigm’s funding runway is positioned to support key upcoming milestones, including the interim analysis expected once half of the trial participants reach Day 112, projected for mid-2026.

Broader Portfolio and Strategic Initiatives

Beyond the human clinical program, Paradigm continues to develop its veterinary osteoarthritis portfolio, including the Pentacoxib™ combination program targeting the animal health market. This strategy aims to complement human health opportunities while maintaining capital discipline.

Engagement with patient advocacy groups and former professional athletes with knee osteoarthritis underscores Paradigm’s commitment to collaborative clinical and community relationships. The company also notes the upcoming expiry of PAROA loyalty options in February 2026, reflecting ongoing corporate governance and shareholder engagement activities.