Paradigm Biopharmaceuticals (ASX:PAR) Sets the Stage for Next Growth Chapter with Phase 3 Trial Launch

April 29, 2025 05:11 PM AEST | By Team Kalkine Media

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Paradigm Biopharmaceuticals (ASX:PAR) Sets the Stage for Next Growth Chapter with Phase 3 Trial Launch — Image source: Shutterstock

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Highlights

Paradigm Biopharmaceuticals launches Phase 3 trial for knee osteoarthritis treatment

Strong financial position with $24.56 million cash balance reported

Shareholder loyalty initiatives introduce potential for over $110 million in future capital

Paradigm Biopharmaceuticals (ASX:PAR) has taken a significant step forward, securing centralised Human Research Ethics Committee (HREC) approval in Australia to initiate a multi-site Phase 3 clinical trial. The study focuses on injectable Pentosan Polysulfate Sodium (iPPS) for the treatment of knee osteoarthritis, a condition affecting millions worldwide. With patient dosing anticipated to commence in the second quarter of calendar year 2025, the company has entrusted Advanced Clinical as the global Contract Research Organization (CRO) to guide the trial's execution.

This milestone represents a major transition for Paradigm Biopharmaceuticals (PAR), shifting from regulatory processes to operational trial delivery. The trial aims to build on the promising outcomes demonstrated during previous Phase 2 studies, where iPPS showed substantial clinical potential in addressing osteoarthritis symptoms.

On the financial front, Paradigm Biopharmaceuticals (PAR) reported a robust cash position, closing the March 2025 quarter with $24.56 million in reserves. The company's cash outflows for the quarter amounted to $6.49 million, impressively under budget by $5.51 million compared to forecasts. This disciplined financial management was further boosted by a $6.3 million refund received under the FY24 R&D Tax Incentive scheme, extending the company's financial runway to support its upcoming clinical and corporate milestones.

In addition to advancing its clinical program, Paradigm Biopharmaceuticals (PAR) introduced shareholder initiatives aimed at strengthening its capital structure. The Loyalty and Piggyback Option Offers launched during the March quarter provide current shareholders with options to participate in future growth opportunities, with the potential to raise over $110 million in additional funds.

Managing Director Paul Rennie emphasised the importance of resilience and adaptability during a time of broader macroeconomic challenges for the biotechnology sector. He highlighted Paradigm Biopharmaceuticals’ (PAR) commitment to delivering on its operational goals, including site activations, patient enrolments, and the first patient dosing milestones scheduled for the upcoming June quarter. Rennie acknowledged the company's strong foundation of clinical evidence, built on consistent Phase 2 results and real-world data, as critical to maintaining momentum and shareholder confidence.

As Paradigm Biopharmaceuticals (PAR) advances into its next chapter, its strategic focus, robust cash position, and shareholder support position it well to capture opportunities ahead.

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