Paradigm Biopharmaceuticals Ltd. (ASX: PAR) Announces Key Achievements in Quarterly Report
Phase 3 Trial Clearance
Paradigm Biopharmaceuticals Ltd. (ASX: PAR) has received clearance from the FDA for its revised protocol in the Phase 3 PARA_OA_012 trial. This successful completion of the FDA’s 30-day review period allows the company to proceed with its planned Phase 3 trial for knee osteoarthritis.
Financial Highlights
In the December quarter, Paradigm successfully raised $16 million through a placement, issuing 40 million shares at $0.40 each. The company’s quarter spend was significantly under budget at $3.58 million, well below the projected $7 million, and it received $6.3 million under the Australian Government’s R&D Tax incentive rebate. Currently, Paradigm’s cash balance stands at approximately $31 million, positioning it well for upcoming activities.
Clinical Development Progress
Paradigm has submitted its centralised ethics application in Australia for the Phase 3 trial, with approval expected shortly. This streamlined process is designed to enhance the trial initiation by expediting clinical site activation and participant recruitment.
Future Outlook
As Paradigm moves towards initiating patient enrolment in Q1 CY2025, it will focus on setting up clinical trials at up to 10 sites across Australia. The company is also preparing to introduce a loyalty option program for shareholders, which aims to enhance investor engagement.
Research and Development Initiatives
Paradigm is nearing the selection of a Contract Research Organisation (CRO) to manage the global Phase 3 trial. The anticipated interim analysis will take place after 50% of participants complete their follow-up. The company is committed to enhancing the scientific visibility of its clinical data through forthcoming manuscript submissions based on Phase 2 trial results.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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