Polarean (POLX) has released its final results for the year ended 31 December 2020 including key operational highlights and a significantly strengthened balance sheet following tis £27m placing post period end to fund the commercialisation of its proprietary drug-device combination product for magnetic resonance imaging ("MRI").

FY20 Operating Highlights

The key operational highlight during the period was the successful competition and submission of the New Drug Application and its acceptance for review by the US Food & Drug Administration following successful Phase III clinical trials, where both trials met their primary endpoint.

In addition, the Company continued to invest in its intellectual property portfolio during the year expanding the patent portfolio into new territories and making additional progress with existing patent filings that involve the gas exchange and pulmonary vascular disease.

The group has clearly continued to push the design of the systems forward, with key advances in ‘ease of use’ and ensuring the manufacturing costs of the machines were in line with future plans.
Impotently, the Company also made valuable progress on its software and image display projects, which will undoubtedly come into play in the near future as the company approaches global commercialisation.

FY20 Financial Highlights

Whilst revenue was significantly below last year at US$1.1m (FY19; US$2.3m), overheads were tightly controlled to ensure the Company Loss Before Tax of US$6.5m (FY19; US$6.1m) was broadly in-line with market expectations.

Importantly, pricing and gross margins of equipment sales were maintained during the period.

Basic and diluted loss per share was therefore US$0.044 (FY19; US$0.057).

Net cash outflow from operations was US$5.8m (FY19; US$5.0m) with cash and cash equiv. at the period end increasing to US$6.3m post the receipt of US$10.7m from the placing completed during the period.

Post period end, the Company successfully raised a further £27m by way of placing, subscription and open offer, to fund the Company through commercialisation and launch programmes and accelerate follow-on trials.

Outlook

The Company’s primary operating focus for the coming year will be the planning and preparation for commercial launch.

The Company has confirmed it already has the necessary resources and skills for commercial launch, especially following the strategic investment from Bracco Imaging during the last funding round, who have unique insight into the global market for medical imaging.

The company expects to receive FDA approval in the second half of 2021

View from Vox

It is still the case that the majority of POLX systems are procured through grant mechanisms and its therefor reassuring for investors to see US$1m of revenue despite the disruption caused by the global pandemic.

We were particularly pleased to see the Company execute an open offer during the latest funding round, demonstrating its commitment to treating all shareholders fairly, and funding the Company through FDA approval and commercial launch.

The shares in POLX have performed exceptionally strongly over the past 12 months, increasing from 26p to open at 94p following publication of its results. Indeed the shares have advanced approximately 50% over the past three months following the placing, demonstrating significant appetite for the shares in the open market.

 

Reasons to  POLX

The Group and its wholly owned subsidiary, Polarean, Inc. are revenue generating, medical drug-device combination companies operating in the high-resolution medical imaging market.  

Polarean’s equipment enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe).  

The Group utilises the hyperpolarised Xenon gas (129Xe) as an imaging agent in order to visualise ventilation and gas exchange regionally in the smallest airways of the lungs, the tissue barrier between the lung and the bloodstream and in the pulmonary vasculature.   

Polarean operates in an area of significant unmet medical need and its technology aims to provide a diagnostic approach, offering a non-invasive and radiation-free functional imaging platform which is more accurate and less harmful to the patient than current methods.   

The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.  

In December 2020, Polarean confirmed that the US FDA had accepted the Group’s new drug application (NDA) for its drug device combination product using hyperpolarised xenon-129 gas.The US regulator informed the Group that the NDA will follow a “standard time frame”.  

This means that the target Prescription Drug User Fee Act or PDUFA date is now 5 October 2021 - this being the deadline by which the FDA must review all new drug applications.  

Hullihen told investors, "FDA acceptance for the filing of Polarean's NDA represents another important step forward for the Company's platform. If approved, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease.”  

Polarean told investors that following the achievement of this latest milestone, that it plans to make ‘full use of this time with regards to commercialisation and launch preparation.’