Paradigm raises $16m for phase III trial of knee osteoarthritis treatment
Health & Biotech
Health & Biotech
Special Report: Paradigm Biopharmaceuticals has received firm commitments for $16 million through a placement to sophisticated and institutional investors, supporting the start of its upcoming phase III trial.
Paradigm Biopharmaceuticals (ASX:PAR) said the placement received strong interest from new and existing institutional and sophisticated investors both domestically and internationally.
Under the placement 40 million shares will be issued at 40 cents/share representing a 10.6 discount to the 15-day volume weighted average price (VWAP) and 2.9% premium to the 30-day VWAP.
Bell Potter Securities acted as sole lead manager and bookrunner to the placement, while Blue Ocean Equities acted as co-manager.
Paradigm intends to issue one listed option for every four shares held at the record date. These loyalty options are exercisable at 65 cents with a 12-month expiry from the record date.
The record date for the loyalty options will be four business days following lodgement of a prospectus for the loyalty options, expected in late January 2025.
Upon exercise of every two loyalty options, the holder will receive one piggyback option, exercisable at $1, expiring 24 months from the date of expiry of the loyalty options.
Proceeds of the capital raising will be allocated to support the clinical trial setup for PARA_OA_012, Paradigm’s phase III clinical trial of the repurposed pentosan polysulfate sodium (aka PPS, aka Zilosul) to treat knee osteoarthritis (OA).
Global initiation and site recruitment in Australia for the trial is expected in Q1 CY25 with recruitment starting in the US in Q2 CY25.
Source: Paradigm Biopharmaceuticals
Paradigm is forecasting it will be well funded following heading into the phase III trial with a $29.6m pro forma cash balance following the placement.
In addition, the exercise of all loyalty options could raise up to an additional ~A$63.3 million from shareholders by early CY26.
Futhermore, the company intends to seek non-dilutive funding through a partnering or regional licensing deal to materially extend its runway.
2025 is shaping up to be a year of catalysts for Paradigm, which recently announced the US FDA had successfully concluded a 30-day review period for its phase III trial protocol, clearing the way for a start date in Q1 CY25.
Paradigm said no substantive questions or concerns were raised by the FDA and the company could proceed with the pivotal clinical trial, using the 2mg/kg twice-weekly dosing regimen of injectable (subcutaneous) pentosan polysulfate sodium (iPPS).
The trial aims to demonstrate improvement in pain and function with subcutaneous injections of iPPS compared with subcutaneous injections of placebo in participants with knee OA pain.
The duration of the study will be up to 64 weeks with treatment duration six weeks.
The visit frequency will be twice weekly during treatment, reducing to every 4–6 weeks during the 52-week follow-up.
The primary endpoint of the phase III is a change from baseline at day 112 in knee pain, assessed by the weekly average daily pain score on the 11-point (0–10) numerical rating scale.
There are several key secondary and additional endpoints assessing the impact of PPS on knee pain and function from baseline through to day 365 including stiffness, quality of life and use of rescue medication.
Long-term assessment of knee structure via MRI and X-ray will be undertaken.
Phase II clinical trial data demonstrated a single six-week course of subcutaneous iPPS can provide 12-month pain relief and improved function in knee OA sufferers.
An outline of the timeline for the trial Phase III can be seen below:
Source: Paradigm Biopharmaceuticals
Managing director Paul Rennie said the capital raised provided Paradigm with sufficient cash reserves to commence the start-up of the phase III clinical trial and working capital into H2 CY25.
“We received support from our current and new investors, which highlights the strength of our clinical programs and positions Paradigm to immediately advance our global phase III clinical trial setup and deliver on critical milestones,” he said.
“2024 has been an important year of dealing with regulatory agencies, and now we are looking forward to the execution of our Phase 3 clinical trials to move ever closer to bringing iPPS to those suffering from seriously debilitating pain and dysfunction.”
This article was developed in collaboration with Paradigm Biopharmaceuticals, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.