Polarean Imaging plc (AIM: POLX), a clinical stage medical imaging technology company developing a proprietary magnetic resonance imaging (MRI) drug-device combination, announces its audited final results for the year ended 31 December 2019.
In addition, Polarean confirms that the Annual Report and Accounts for the year ended 31 December 2019, 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 2 p.m. BST on 13 July 2019.
Highlights
· Raised £2.1 million (gross) via a placing of 11,666,667 ordinary shares at a placing price of 18p per share in July 2019
· Third trial site added at University of Cincinnati, in addition to Duke University and the University of Virginia, to improve enrolment rates for its two pivotal Phase III Clinical Trials (the “Clinical Trials”)
· Completion of patient enrolment for the Clinical Trials in November 2019
· Sale and Installation of three new Polarean 9820 Xenon Polariser systems to the University of British Columbia, The Hospital for Sick Children in Toronto and the University of Iowa Hospitals and Clinics. Receipt of an order for a new Polarean 9820 Xenon Polariser system from the University of Kansas
· Third tranche of US$1m confirmed from US$3m Small Business Innovation Research grant
· Net cash of US$2.0 million at 31 December 2019
Post-period end
· Positive top-line results from the Clinical Trials using hyperpolarised 129Xenon gas, where both trials met their primary endpoint
· Raised £8.4 million (gross), including the £2.2 million subscription from new strategic investor Bracco Imaging S.p.A.
· Appointment of Jonathan Allis as Chairman
· Appointment of Cyrille Petit as Non-Executive Director
· Completion of a pre-New Drug Application meeting (“pre-NDA meeting”) with the United States Food and Drug Administration (“FDA”)
Richard Hullihen, CEO of Polarean, commented: “2019 has been a year of great accomplishment for Polarean. Our critical goal of executing and managing our pivotal Phase III Clinical Trials was rewarded with a successful readout in January 2020, which is a major milestone for us. Following this we raised a further £8.4 million which will enable us focus on preparing our NDA submission to the FDA in Q3 2020. We remain hopeful that this will lead to regulatory approval in H2 2021.
“We also welcome our new strategic investor, Bracco Imaging S.p.A and look forward to growing this mutually beneficial relationship. We are confident and excited for the future of Polarean and are grateful to our shareholders and stakeholders for their continued support.“
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