Paradigm Biopharma Advances Phase 3 Trial, Secures $50M Funding Runway

Clinical Milestone Achieved

Paradigm Biopharmaceuticals has reached a pivotal juncture with the commencement of participant dosing in its global Phase 3 clinical trial (PARA_OA_012) for injectable pentosan polysulfate sodium (iPPS), targeting pain relief in knee osteoarthritis. This milestone confirms operational readiness across multiple sites in Australia and the United States, with the majority of trial locations now active and recruiting.

Early screening data from the trial indicate a notable improvement in screen-failure rates compared to Paradigm's earlier Phase 2 study, reflecting refinements to the clinical protocol guided by the US Food and Drug Administration. This enhanced screening efficiency may reduce the total number of sites required to meet recruitment targets, potentially accelerating the trial timeline.

Robust Financial Position Supports Progress

Paradigm's financial footing remains solid, with a cash balance of approximately A$19.68 million as of 30 September 2025, supplemented by an additional A$30.29 million available through a convertible note facility with Obsidian Global Partners. This funding runway is expected to support the company through the planned interim analysis, anticipated in mid-2026 when 50% of participants reach Day 112 of the study.

During the quarter, Paradigm drew down US$7 million (A$10.68 million) from this facility to fund ongoing clinical operations, including site activations and investigational product manufacturing. The company also completed a strategic acquisition of Proteobioactives Pty Ltd, securing global intellectual property rights to Pentacoxib™, an oral combination therapy aimed at earlier-stage osteoarthritis and veterinary applications. This acquisition broadens Paradigm's osteoarthritis portfolio beyond its injectable PPS program, positioning the company for diversified development opportunities.

Corporate and Investor Engagement Initiatives

Paradigm has taken steps to enhance shareholder engagement and streamline corporate governance. The launch of a dedicated InvestorHub platform offers real-time access to company updates, multimedia content, and interactive Q&A sessions, fostering transparency and investor involvement. Additionally, the company implemented an Unmarketable Parcel Sale Facility to reduce administrative costs by enabling shareholders with small holdings to sell shares without brokerage fees.

At the September Extraordinary General Meeting, shareholders approved all resolutions, including those related to the convertible note facility, providing Paradigm with operational flexibility to manage funding tranches while preserving shareholder value. The company also actively participated in investor conferences in Sydney and Hong Kong, broadening its profile among healthcare investors.

Looking Ahead – Recruitment and Regulatory Milestones

Paradigm is focused on accelerating recruitment to reach 50% enrolment by the end of 2025, setting the stage for the interim analysis in mid-2026. This analysis, overseen by an independent Data Safety Monitoring Board, is a critical clinical and commercial catalyst that could provide early signals of efficacy and inform regulatory and partnering strategies.

The company is also exploring the addition of trial sites beyond Australia and the US to support recruitment momentum. Meanwhile, Paradigm continues to prioritize cost discipline and resource allocation to maintain operational efficiency as it advances toward full recruitment and subsequent clinical milestones.