Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) continues to build up its commercial organisation in anticipation of a successful launch as soon as it secures approval from the US Food and Drug Administration (FDA), chief executive Richard Hullihen said in the company’s final results statement.
Since the turn of the year, Polarean has re-submitted a New Drug Application (NDA) to the FDA, after October’s FDA response letter.
"We spent much of the year gearing towards our anticipated FDA approval, although the FDA confirmed in October that they were unable to approve the NDA in its current form due to some technical or manufacturing-related issues centred around the xenon hyperpolariser system,” Hullihen said.
“We worked hard with consultants and collaborators to thoroughly address the items raised and successfully resubmitted our application post-period end, in March 2022.”
Fundraising was a key achievement for the first half of the last financial year, with an oversubscribed placing in April 2021 bringing in £27mln, to mark Polarean’s largest financing to date.
As highlighted by Hullihen, it introduced several significant new institutional investors along with support from existing strategic, institutional and retail investors.
In the current financial period, Polarean is also advancing research alongside McMaster University, in Ontario, Cincinnati Children's Medical Center, and Oxford University Hospitals NHS Trust – with the latter collaboration focussing on ‘long-COVID’.
“We continue to identify exciting opportunities in the areas of COVID-19, cardiology and pulmonary vascular disease and these prospects should expand the use of the company's technology in the future.
“Although the delay in FDA approval is disappointing, we are using this time to continue to explore potential future applications for our technology.”
In terms of the financial results, the company ended 2021 with US$28.9mln of net cash. A sum that could potentially finance the company into 2024, it highlighted.
Polarean had US$1.18mln of revenue in the year and reported a US$508,025 gross profit and a net loss of US$14mln.