Paradigm Biopharmaceuticals (ASX:PAR) has marked 2025 as a transformative year, moving from regulatory preparation to the active execution of its global Phase 3 clinical trial for iPPS (Zilosul) in knee osteoarthritis, while also strengthening its financial foundations and broadening its treatment pipeline.
The year began with a milestone when the US FDA accepted the final protocol for the pivotal PARA_OA_012 study without further comment, clearing the way for Paradigm to proceed. By the end of the 2025 financial year, 27 clinical sites had been initiated across Australia and the US, with patient screening already underway. The trial will enrol 466 participants.
Chief Medical Officer Dr Donna Skerrett described 2025 as a turning point for the company, saying that after years of rigorous development, Paradigm is now delivering on the promise of a global registrational trial executed at scale.
Paradigm secured two major financings, ensuring the program could progress without interruption. In December 2024, the company raised $16 million in equity to fund startup activities, including CRO engagement, regulatory submissions, and the manufacture of an investigational product.
Then, in July 2025, it signed a US$27 million (A$41.2 million) convertible note facility with Obsidian Global Partners, providing the capital runway to carry the trial through to its planned interim analysis in mid-2026.
Founder and Managing Director Paul Rennie said the structure of the financing reflected shareholder feedback, which emphasised funding certainty with minimal dilution. “We listened and prioritised a robust capital strategy that preserves long-term value while enabling uninterrupted execution of our global program,” he said.
Beyond its lead injectable therapy, Paradigm also broadened its osteoarthritis pipeline with the acquisition of Pentacoxib, a novel oral combination of pentosan polysulfate sodium and a COX-2 inhibitor targeting earlier-stage disease. The addition complements Zilosul, which is focused on patients with moderate to severe osteoarthritis. It represents a stage-based treatment strategy that could ultimately allow the company to serve the full spectrum of disease severity. The initial focus will be on developing Pentacoxib for veterinary osteoarthritis, generating translational data to support eventual human applications. Early observations suggest the combination could provide a safer oral alternative to long-term NSAID use, with the potential to reduce flare-ups and improve adherence.
Paradigm reported revenue of $7.1 million in 2025, a more than tenfold increase from the prior year, primarily supported by R&D incentives and other income streams. The company’s net loss narrowed to $18.8 million from $40 million in 2024, representing a significant improvement, reflecting disciplined cost management alongside the focused investment required to transition into large-scale clinical execution.
Paul Rennie said the coming year represents the most important chapter in Paradigm’s journey to date. “With strong operational momentum, a disciplined capital structure, and a pipeline spanning early to late-stage osteoarthritis, we are positioned to deliver on our mission to transform care for millions of patients worldwide,” he said.