Appendix 4D and Half Year Report
| Stock | Paradigm Biopharmaceuticals Ltd (PAR.ASX) |
|---|---|
| Release Time | 27 Feb 2026, 8:11 a.m. |
| Price Sensitive | Yes |
Paradigm Biopharmaceuticals Advances Toward Interim Analysis
- Pivotal Phase 3 clinical trial PARA_OA_012 progressing with 50% enrollment target for mid-2026 interim analysis
- Expanded global clinical footprint to include sites in Hong Kong and Moldova
- Strengthened scientific foundation through peer-reviewed publications on biomarkers and imaging
- Acquired global IP rights for oral PPS and COX-2 inhibitor combination therapy
During the half-year ended 31 December 2025, Paradigm Biopharmaceuticals Ltd continued to advance its lead osteoarthritis program toward a critical development milestone, being the planned interim analysis of its global Phase 3 PARA_OA_012 clinical trial targeted for mid-calendar year 2026. The Company's strategic focus remains the successful delivery of this interim analysis, a key inflection point in the development pathway of injectable pentosan polysulfate sodium (iPPS). The interim analysis is designed to provide an early, statistically robust assessment of safety and efficacy outcomes once approximately 50% of participants have reached the Day 112 assessment point. Successful completion of this milestone has the potential to materially reduce development risk and strengthen the foundation for subsequent regulatory, commercial and partnering activities. Paradigm's progression toward interim analysis is occurring against a backdrop of improving global biotechnology market conditions, with late-stage biotechnology assets with clearly defined clinical catalysts and adequate funding increasingly attracting institutional interest and strategic attention. Paradigm has prioritised maintaining a funding position that supports uninterrupted progression toward the interim analysis milestone, including the utilization of its US$27 million convertible note facility. In parallel with clinical execution, Paradigm continues to strengthen the scientific and regulatory foundations of its development programs through peer-reviewed publications, biomarker validation and advanced imaging analysis. During the half-year, Paradigm also expanded its osteoarthritis pipeline through the acquisition of global intellectual property rights to an oral pentosan polysulfate and COX-2 inhibitor combination therapy.
Paradigm's near-term focus remains on delivering a high-quality interim data package based on rigorous trial execution, consistent methodology and strong operational oversight. Subject to favourable interim outcomes, the Company expects this milestone to represent a significant step toward further de-risking, enhanced commercial engagement and progression toward potential registration.