• Phase 3 milestone achieved with participants dosed in Australia and US
• Site activation on track, with improved screening performance
• Shareholder engagement initiatives launched, including InvestorHub platform
• EGM resolutions passed, including approval for additional convertible notes

Paradigm Biopharmaceuticals Ltd. (ASX: PAR) has provided a comprehensive update on its activities for the September 2025 quarter, highlighting key milestones in its pivotal Phase 3 clinical trial for injectable pentosan polysulfate sodium (iPPS) in knee osteoarthritis. The company has now dosed participants in both Australia and the United States, confirming operational readiness across multiple trial sites. Site activation continues to ramp up, and early screening data indicate a significant improvement in screen failure rates compared to the earlier PARA_OA_002 study. Paradigm is implementing a multi-layered patient recruitment strategy, including its dedicated Hope4OA platform and targeted digital advertising programs, to ensure timely enrolment. On the financial front, Paradigm held A$19.68 million in cash at the end of the quarter, with an additional A$30.29 million available through a convertible note facility with Obsidian Global Partners. The company also completed the acquisition of Proteobioactives Pty Ltd, securing global IP rights to Pentacoxib, an oral PPS + COX-2 combination targeting earlier-stage osteoarthritis and veterinary indications. Paradigm continues to strengthen its investor engagement, launching a dedicated InvestorHub platform and participating in key investor events. The company's near-term priorities are to accelerate recruitment, maintain cost discipline, and ensure it remains on track for the planned interim analysis in mid-2026, which represents a key clinical and commercial catalyst.

Paradigm expects total cash outflows for the December 2025 quarter to be in the range of A$13-15 million, driven by the operational ramp-up across multiple clinical sites and the expansion of recruitment and monitoring activities.

Paradigm enters the December quarter with a clear operational focus on accelerating recruitment and dosing across its global Phase 3 clinical trial (PARA_OA_012) of iPPS for knee osteoarthritis. The company is targeting 50% participant enrolment by the end of CY2025, which will position PARA_OA_012 for its interim analysis, planned once half of participants reach Day 112, anticipated mid-2026. The analysis, overseen by an independent Data Safety Monitoring Board (DSMB), represents a key clinical and commercial catalyst for Paradigm, potentially providing early efficacy signals and informing future regulatory and partnering discussions.