• 50% of patients dosed in global Phase 3 PARA_OA_012 study
• Interim analysis results expected in Q3 2026
• Expanded global trial footprint with Hong Kong and Moldova sites
• Positive biomarker and translational study publications

Paradigm Biopharmaceuticals provided an update on its Q1 2026 activities, including key progress in its global Phase 3 PARA_OA_012 clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) for the treatment of knee osteoarthritis. The company achieved the milestone of 50% of patients dosed in the study, supporting the planned pathway toward interim analysis. The interim analysis results are expected in Q3 2026, subject to data cleaning, biometrics review, and independent statistical analysis. Recruitment and dosing activity continued to build across the global site network, with the addition of a new clinical trial site in Hong Kong and planned expansion into Moldova. Paradigm also highlighted the publication of positive biomarker and translational study data, providing further scientific and mechanistic validation for iPPS. The company maintained a strong cash position, with additional funding secured through a placement and convertible note facility, supporting operations into the post-interim analysis period.

Total cash outflows for the June 2026 quarter are forecast to be in the range of A$14-16m, driven by the peak costs associated across recruitment, screening, dosing and monitoring activities as the clinical trial progresses to 100% recruitment.

Paradigm's primary near-term focus remains the interim analysis, which is expected to occur in Q3 CY2026. Following the interim analysis, the company expects to complete the Phase 3 study with primary endpoint top-line results expected in Q1 CY2027. Paradigm also announced a transition for the Chief Medical Officer, with a process underway to appoint a full-time replacement.