• Phase 3 Knee OA Trial Recruitment Progressing
• International Site Expansion Underway
• Interim Analysis Timeline on Track
• Scientific Publications Validate Biomarker Findings

Paradigm Biopharmaceuticals Ltd. (ASX: PAR) provided its quarterly update for the three months ended 31 December 2025, highlighting continued progress on its global Phase 3 PARA_OA_012 clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) for the treatment of pain associated with knee osteoarthritis. The majority of selected clinical sites across Australia and the United States are now active and recruiting, with screening and enrolment activity continuing to build across regions. Paradigm also expanded its global Phase 3 footprint through the engagement of Nordic Bioscience Clinical Development (NBCD) as a complementary CRO, with four additional high-performing clinical sites being activated in Hong Kong and Moldova. Recruitment progress remains aligned with the company's planned pathway toward interim analysis, which is expected to occur in mid-calendar year 2026. Subsequent to the quarter, Paradigm announced the acceptance and publication of its Phase 2 PARA_OA_008 biomarker manuscript in a leading international peer-reviewed journal, representing an important external validation of the quality and relevance of the company's Phase 2 data. Paradigm also noted that a separate manuscript reporting outcomes from a translational canine osteoarthritis study is currently progressing through the peer-review process. The company ended the quarter with a cash balance of approximately A$14.66 million and an additional A$22.41 million in available facility, providing a strong funding position to support ongoing clinical execution.

Paradigm expects to receive an R&D tax incentive rebate of approximately A$6.2m during the quarter. Total cash outflows for the March 2026 quarter are forecast to be in the range of A$12-15m, driven by the operational ramp-up across multiple clinical sites and the expansion of recruitment, screening, dosing and monitoring activities.

Paradigm enters the March quarter with a clear operational focus on continued execution of its global Phase 3 PARA_OA_012 clinical trial. The company anticipates a significant ramp-up in recruitment activity through the quarter and expects to achieve the 50% recruitment milestone, positioning the study to progress toward the planned interim analysis in mid-calendar year 2026. Paradigm also continues to advance its broader osteoarthritis portfolio strategy, including development activities for the PPS × COX-2 inhibitor combination program (Pentacoxib™) for the veterinary market.