Polarean Imaging (AIM:POLX) has described 2019 as “a year of great accomplishment” in its final results for the year ended 31 December 2019 after the group achieved a successful readout for its pivotal Phase III clinical trials in January 2020.
The medical imaging specialist highlighted that it had benefited from raising £2.1m in a share placing in July 2019 which provided additional support for the group’s clinical trials as patient enrolment neared completion.
While 2019 overall results were consistent with market expectations, revenues were slightly below expectations at US$2.3m, down from $2.4m in FY2018, ‘but with expenses diligently managed to also be lower than expectations,’ the group highlighted.
Despite the tight cost control, Polarean reported an increase in pre-tax loss to $6.1m compared to a $5.4m loss in the prior year.
The group said it had also benefited from a confirmed third tranche of $1m from a $3m small business innovation research grant with Cincinnati Children's Hospital Medical Center.
The group’s net cash as at 31 December 2019 therefore stood at US$2.0m, up from $0.88m in 2018.
Shares in Polarean Imaging were trading 8.93% lower at 25.5p on Thursday morning.
“2019 has been a year of great accomplishment for Polarean,” said Richard Hullihen, CEO of 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.”
Post-period, the group said it had received positive top-line results from the clinical trials using hyperpolarised Xenon gas, with both trials meeting their primary endpoint.
Polarean also successfully raised a further £8.4m, on 13 March 2020, which includes a £2.2m subscription from new strategic investor Bracco Imaging, which Hullihen said would enable the group to focus on preparing its New Drug Application submission to the FDA in the third quarter of 2020.
“We remain hopeful that this will lead to regulatory approval in H2 2021,” Hullihen noted.
Polarean said “it continues to explore opportunities with further partners in Pharma and in other geographic markets which “may bring economic benefits to the group going forward.”
“We are confident and excited for the future of Polarean and are grateful to our shareholders and stakeholders for their continued support,” added Hullihen.
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