Polarean Imaging Points to Commercial Launch
, the medical-imaging technology company, has released its 1H20 results for the six months ended 30 June 2020.
The progress towards its goal of seeking FDA approval for the Company’s proprietary investigational drug-device combination diagnostic for magnetic resonance imaging ("MRI") now points towards submission of the New Drug Application (“NDA”) in early October 2020 with full commercial launch before the end of 2021.
Financial Highlights
Group revenues for the first half were $0.3m (1H19: $0.4m) and were largely derived from the collaboration with the University of Cincinnati where work under the SBIR grant has been completed.
The company development kept overheads under strict control during the period at $2.7m (1H19: $3.1m) to report a loss before tax of $3.2m (1H19: $3.4m).
During the period the Company raised gross proceeds of £8.4m in April 2020, which included a £2.2m subscription from new strategic investor Bracco Imaging S.p.A. ("Bracco"), to close the period as of 30 June at $9.2m.
Post-period end
The Company reported it has made ‘significant progress’ towards submitting its New Drug Application ("NDA"), which is now expected to be submitted in early October 2020.
Importantly, the Company was granted the “Small Business Waiver of Human Drug Application Fee” granted by the United States Food and Drug Administration ("FDA") on 28 September 2020.
Furthermore, it has already installed a “9820 Xenon Polariser” system at the University of Kansas Medical Center ("KU Medical Center") and presented at the American Thoracic Society and the International Society for Magnetic Resonance in Medicine virtual conferences post the period end.
The Company is also aware users of the devices are successfully applying for Government COVID-19-related grants, including a recent award for a multi-center initiative coordinated by Western Ontario Professor Grace Parraga PhD, to better understand the long-term effects of COVID-19 using hyperpolarised 129Xe MRI in combination with computed tomography (CT).
Richard Hullihen, CEO of Polarean, commented: "During the period under review, Polarean achieved one of its most important milestones to date, the positive readout from our Phase III Clinical Trials. We subsequently undertook an £8.4m fundraising and welcomed our new strategic investor Bracco to our share register, alongside several new institutional investors. We are also grateful for the continued support we received from our existing long-term investors and partners."
Shares in POLX have performed strongly over the past three months from lows of 32.5p in July to open at 43p following publication of the 1H20 report.
Outlook
The Company has recently entered into the field of cardiology and pulmonary vascular disease, which is one example of the further potential of the technology, is also evaluating new uses of the technology in pharmaceutical drug development with approximately 40 clinical trials currently ongoing into the use of 129Xe MRI according to the FDA website.
“The installation of new polarisers has continued and users of our systems are publishing research at an increased rate, expanding and deepening the knowledge base of the use of hyperpolarised 129Xe in pulmonary medicine, while further validating Polarean's technology. We look forward to providing our shareholders with updates regarding further progress and specifically the imminent submission of the Company's NDA to the FDA." Added Richard.
The Company believes the drug-device combination utilising 129Xe offers the ideal solution for improving pulmonary disease diagnosis and believes the final stages of submitting the NDA will lead to commercial launch before the end of 2021.
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