Polarean Imaging upbeat on progress as losses widen

The AIM-traded firm said its operating loss widened to $6.62m for the year ended 31 December, from $6.01m a year earlier, while its loss before tax was $6.53m, compared to $6.1m in 2019.

Its basic and diluted loss per share came in at 4.4 US cents for the year, narrowing from 5.7 cents 12 months prior.

On the operational front, Polarean noted positive top-line results from the phase 3 clinical trials using hyperpolarised 129Xenon gas during the year, where both trials met their primary endpoint.

The company raised £8.4m in the period, including a £2.2m subscription from new strategic investor Bracco Imaging.

It appointed Jonathan Allis as its non-executive chairman, and Cyrille Petit as a non-executive director and representative of Bracco, and completed a pre-new drug application meeting with the United States Food and Drug Administration (FDA).

Its new drug application was accepted for review by the FDA, with a target Prescription Drug User Fee Act (PDUFA) action date of 5 October 2021.

At year-end, the company had net cash of $6.3m.

Since the year ended, Polarean raised £27m in an oversubscribed financing, including support from strategic investors Bracco and Nukem Isotopes, as well as institutional investor Amati AIM VCT, joined by several new UK and US institutional investors.

Chief financial officer Chuck Osborne had been appointed to the board, and the firm had completed the mid-cycle review of its new drug application submission with the FDA.

The first peer-reviewed Covid-19 research by professor Fergus Gleeson at the University of Oxford was also published, and the company received an additional research unit order for a 9820 Xenon Polariser system from the University of British Columbia in Vancouver.

“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 3 clinical trials in early 2020,” said chief executive officer Richard Hullihen.

“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.”

At 1217 BST, shares in Polarean Imaging were up 2.44% at 95.27p.