Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product for magnetic resonance imaging (MRI), announces its audited final results for the year ended 31 December 2020.
In addition, Polarean confirms that the Annual Report and Accounts for the year ended 31 December 2020, the Notice of the Annual General Meeting ("AGM") and a Form of Proxy are now available on the Company's website (http://www.polarean-ir.com/content/investors/annual-reports.asp) and will be posted to shareholders shortly.
Polarean's AGM will be held at 2500 Meridian Parkway, Suite 175, Durham, NC 27713, USA at 2pm BST / 9am EST on 13 July 2021.
· Positive top-line results from the Phase III clinical trials using hyperpolarised 129Xenon gas, where both trials met their primary endpoint
· Raised £8.4 million (gross), including a £2.2 million subscription from new strategic investor Bracco Imaging S.p.A. ("Bracco")
· Appointment of Jonathan Allis as Non-Executive Chairman
· Appointment of Cyrille Petit as Non-Executive Director and representative of Bracco
· Completion of a pre-New Drug Application ("NDA") meeting with the United States Food and Drug Administration ("FDA")
· Acceptance of the NDA for review by the FDA, with a target Prescription Drug User Fee Act ("PDUFA") action date of 5 October 2021
· Net cash of US$6.3 million as of 31 December 2020
· Raised £27 million gross proceeds in an oversubscribed financing, including continued support of strategic investors, Bracco Imaging S.p.A and Nukem Isotopes GmbH as well as institutional investor Amati AIM VCT plc, joined by several new UK and US institutional investors.
· Appointment of Chuck Osborne, Chief Financial Officer, to the Board
· Completion of Mid-Cycle Review of NDA submission with FDA
· Publication of first peer reviewed COVID research by Professor Fergus Gleeson at the University of Oxford
· Additional research unit order for a 9820 Xenon Polariser system from the University of British Columbia in Vancouver, Canada.
Richard Hullihen, CEO of Polarean, commented: "It has been a strong year for Polarean, and we have achieved some significant milestones during the period beginning with the positive readout of our Phase III clinical trials in early 2020. This was followed quickly by a successful placing and subscription in April 2020, and a further oversubscribed fundraise in March 2021 which was needed to fund sales and marketing expenses to build the commercial team and infrastructure, to support ongoing clinical trial, regulatory and medical affairs costs, to support the continued investment in research and development and to provide additional working capital and for general corporate purposes.
"We have made significant Board changes to reflect our progress and we're very excited to have a target PDUFA date from the FDA. On behalf of the whole Board, I would like to thank our employees and shareholders for their ongoing support, and we look forward to further positive updates throughout the rest of the year."