Polarean Imaging PLC (LON:POLX) has hailed a “year of great accomplishment” in 2019 as the company achieved a “major milestone” with a successful readout for its pivotal Phase III clinical trials in January.
Posting its results for the year ended December 31, 2019, the medical imaging specialist noted that it had raised £2.1mln in a share placing in July as well as confirming the third tranche of US$1mln from a US$3mln small business innovation research grant. The company said it ended the year with net cash of US$2mln.
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Post-period, Polarean said it had received positive top-line results from its clinical trials using hyperpolarised Xenon gas, with both trials meeting their primary endpoint.
The firm also said it has raised an additional £8.4mln, £2.2mln of which came from new strategic investor Bracco Imaging, which chief executive Richard Hullihen noted will enable the group to focus on preparing its new drug application (NDA) submission to the US Food and Drug Administration (FDA) in the third quarter of 2020.
Hullihen said the firm was “hopeful” of receiving regulatory approval in the second half of 2021.
In the figures for 2019, Polarean reported a pre-tax loss of US$6.1mln compared to a US$5.4mln loss in the prior year, with revenues slightly lower at US$2.3mln, down from US$2.4mln in 2018.
"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”, Hullihen said in the results statement.
“We are confident and excited for the future of Polarean and are grateful to our shareholders and stakeholders for their continued support", he added.