02 September 2021
Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product for magnetic resonance imaging (MRI), announces its unaudited interim results for the six months ended 30 June 2021.
Statement of Comprehensive Income
Statement of Financial Position
Statement of Changes in Equity
Cash Flow Statement
To view a full version of the results in
Richard Hullihen, CEO of Polarean, commented: “During the first half of 2021 the Company raised its largest financing to date with its oversubscribed £27 million gross proceeds financing. We appreciate the continued support from our existing strategic, institutional and retail investors and welcome several new significant institutional investors. The proceeds from this round are being used to plan and execute the launch of our product in accordance with our current target PDUFA date of 5 October 2021. We continue to sell new polarisers systems for research use, as the amount of polarised Xenon research continues to increase. We look forward to providing our shareholders with updates regarding further progress and specifically the status of our target PDUFA date of 5 October 2021, and we thank them for their continued support on this exciting journey.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.
|Polarean Imaging plc||www.polarean.com / www.polarean-ir.com|
|Richard Hullihen, Chief Executive Officer||Via Walbrook PR|
|Jonathan Allis, Chairman|
|Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)|
|Nicholas Moore / Ben Maddison / Samira Essebiyea (Healthcare Investment Banking)||+44 (0)20 7710 7600|
|Nick Adams / Fred Walsh (Corporate Broking)|
|Walbrook PR||Tel: +44 (0)20 7933 8780 or [email protected]|
|Paul McManus / Anna Dunphy||Mob: +44 (0)7980 541 893 / +44 (0)7879 741 001|
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, investigational drug-device combination companies operating in the high-resolution medical imaging research space.
The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe) as an imaging agent to visualise ventilation. 129Xe gas is currently being studied for visualisation of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue barrier, and into the pulmonary bloodstream.
In October 2020, the Group submitted a New Drug Application (“NDA”) to the FDA for hyperpolarised 129Xe used to evaluate pulmonary function and to visualise the lung using MRI. In December 2020, the Group received confirmation of acceptance of its NDA by the FDA, with a target PDUFA action date of 5 October 2021.
The Group operates in an area of significant unmet medical need and the Group's technology provides a novel investigational diagnostic approach, offering a non-invasive and radiation-free functional imaging platform. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.
The six month period ending 30 June 2021 has seen Polarean make substantial progress towards its goal of seeking FDA approval for the Company's drug-device combination. As in the normal course, post submission, the Company has responded
to the question and answer process with the FDA for our submission, while preparing itself and verifying the preparation of its suppliers and providers.
In January, the Company appointed a new Nominated Advisor and Broker, Stifel Nicolaus Europe Limited, which led to a successful placing, subscription, and open offer which was oversubscribed in every category, including its strategic investors Nukem
Isotopes and Bracco. Then in February, Chuck Osborne, the existing CFO, was appointed to the Board in order to further leverage his extensive experience in early-stage life science company management, build out and fund raising.
During challenging times in healthcare and hospital utilization, we continued to take research orders from leading academic centres such as BC Children’s hospital in Vancouver and also to build and deliver systems, completing the installation
at MD Anderson Cancer Center in Houston.
Presentation at Medical Conferences and Studies Utilising our Technology
The Company's technology was once again prominent at the ATS and ISMRM virtual conference during May 2021 with over 50 abstracts related to the use of hyperpolarised 129Xe accepted for presentation at the two conferences. The
content of our publications and those of our customers, along with our participation is available on our website at www.polarean.com. The user base of our polarisers continues to expand and document the applications of our technology across
the spectrum of pulmonary disease.
Importantly, the first peer reviewed article on COVID-19 Long Haul patients visualised using 129Xe have now been published (https://pubs.rsna.org/doi/10.1148/radiol.2021210033).
Additional investigator-initiated government research grants are underway to study the use of our technology to assess the long-term effects of COVID-19 infection in patients.
Group revenues for the first half were US$0.6m (2020: US$0.3m) and were largely derived from the sale of a polariser system to MD Anderson, in contrast to the H1 2020 revenue, which was largely from our collaboration with the University of Cincinnati for work under our SBIR grant, which has now been completed. We continue to sell our polariser systems on a research-use-only basis to academic institutions in the US, Canada and Europe. Operating expenses for H1 2021 (US$5.5m) increased from H1 2020 (US$3.4m), as Selling and Distribution Expenses (H1 2021 US$1.8m, H1 2020 US $0.4m) increased as we are executing our plans for commercial launch. During H1 2021, the Company recognized Finance Income of US$0.4m due to the strengthening of the British pound, which more than offset the US$0.3m forgivable loan under the US Paycheck Protection Program (“PPP”) we received and recognized as Finance Income in H1 2020. Our overall loss before tax increased from US$3.2m to US$4.9m in the same comparable period, due primarily to the commercial launch preparation expenses. The Company completed a £27m (~$37m) fundraise during H1 2021 via the issue of new equity and as at 30 June 2021 we held US US$38.2m in net cash or cash equivalents.
Post-period end events
FDA review of NDA
We continue to interact with the FDA as they review our NDA with a target date PDUFA date of 5 October 2021.
Preparation for launch
We continue to prepare for the potential launch of our drug device combination post FDA approval. In particular, we have been building a sales and marketing organization with the recent recruitment of several sales positions.
Planning for conference exhibitions
We are continuing to increase the awareness of Polarean technology with exhibitions at CHEST in October 2021 and RSNA in December 2021.
Researchers continue to apply for and receive grants to purchase our polariser systems, most recently BC Children’s Hospital in Vancouver, BC. This system has been delivered and is proceeding to installation. We are in discussions with
several research institutions and anticipate additional possible orders during calendar year 2021.
We continue to demonstrate that Polarean's technology has the potential to be of tremendous benefit to patients and a powerful new tool for clinicians in discovering and characterising treatable traits in pulmonary medicine. In addition, our latest
new techniques lead us into the field of cardiology and pulmonary vascular disease which is one example of the further potential of our technology. We also look forward to evaluating new uses of our technology in pharmaceutical drug development.
The burden of pulmonary disease in the USA is approximately US$150bn and is widespread and growing, affecting nearly 40 million Americans and 500 million worldwide, with post COVID patients comprising a new segment approaching the scale of asthma.
Given the limitations of existing methods of diagnosis and lung disease monitoring, we estimate that there is a significant unmet need for safe, non-invasive, quantitative, and cost-effective image-based diagnosis technology. We believe that our
unique medical drug-device combination utilising 129Xe offers the ideal solution for improving pulmonary disease diagnosis.
This is an exciting time for the Company, as we enter the final stages of submitting our NDA and look towards a potential commercial launch before the end of 2021.
Chief Executive Officer
2 September 2021
|Cost of sales||(323,185)||(41,387)||(346,300)|
|Selling and distribution expenses||(1,799,324)||(351,754)||(917,783)|
|Share based payment expense||(367,397)||(213,906)||(474,716)|
|Loss from operations||(5,240,427)||(3,436,443))||(6,615,562)|
|Loss on ordinary activities before taxation||3||(4,855,296)||(3,178,935)||(6,534,523)|
|Loss and total other comprehensive expense||(4,855,296)||(3,178,935)||(6,534,523)|
|Basic and fully diluted loss per share (US$)||3||(0.026)||(0.023)||(0.044)|
|Property, plant and equipment||233,044||312,287||271,264|
|Trade and other receivables||5,539||5,539||5,539|
|Trade and other receivables||397,473||522,625||348,067|
|Cash and cash equivalents||38,197,203||9,190,862||6,282,665|
|Group reorganisation reserve||7,813,337||7,813,337||7,813,337|
|Share-based payment reserve||2,212,848||1,584,640||1,845,450|
|Trade and other payables||2,549,096||1,985,828||1,348,866|
|Total equity and liabilities||42,698,616||14,325,521||10,880,366|
|Share capital||Share premium||Group re-organisation||Share-based payment reserve||Accumulated losses||Total equity|
|Balance as at 31 December 2019 (audited)||55,776||13,659,912||7,813,337||1,370,734||(18,309,681)||4,590,078|
|Loss and total comprehensive income for the period||-||-||-||-||(3,178,935)||(3,178,935)|
|Issue of shares||21,742||10,427,537||-||-||-||10,449,279|
|Share issue costs||-||(514,391)||-||-||-||(514,391)|
|Balance as at 30 June 2020 (unaudited)||77,518||23,573,058||7,813,337||1,584,640||(21,488,616)||11,559,937|
|Loss and total comprehensive income for the period||-||-||-||-||(3,355,588)||(3,355,588)|
|Transactions with owners|
|Issue of shares||682||275,836||-||-||-||276,518|
|Share issue costs||-||(8,323)||-||-||-||(8,323)|
|Balance as at 31 December 2020 (audited)||78,200||23,840,571||7,813,337||1,845,450||(24,844,204)||8,733,354|
|Loss and total comprehensive income for the period||-||-||-||-||(4,855,296)||(4,855,296)|
|Issue of shares||23,345||37,260,511||-||-||-||37,283,856|
|Share issue costs||-||(2,097,617)||-||-||-||(2,097,617)|
|Balance as at 30 June 2021 (unaudited)||101,545||59,003,465||7,813,337||2,212,848||(29,699,500)||39,431,695|
|Unaudited 6 months ended 30.6.21|
|Unaudited 6 months ended 30.6.20 |
|Audited 12 months ended |
|Cash flows from operating activities|
|Loss for the period before taxation||(4,855,296)||(3,178,935)||(6,534,522)|
|Adjustments for non-cash/non-operating items:|
|Depreciation of plant and equipment||81,320||73,204||150,224|
|Amortisation of intangible assets||375,861||359,677||734,058|
|Share based compensation||367,398||213,906||474,716|
|Changes in working capital:|
|Increase in inventories||(268,387)||(396,462)||(423,093)|
|Increase in trade and other receivables||(49,406)||114,157||288,096|
|Increase/(decrease) in trade and other payables||1,310,426||189,407||(424,714)|
|Increase/(decrease) in deferred revenue||(127,696)||(27,085)||21,576|
|Net cash flows used from operating activities||(3,166,250)||(2,652,223)||(5,794,698)|
|Cash flows from investing activities|
|Purchase of plant and equipment||(43,099)||(29,534)||(65,531)|
|Net cash used in investing activities||(43,099)||(29,534)||(65,531)|
|Cash flows from financing activities|
|Issue of shares||37,283,856||10,449,279||10,725,797|
|Cost of issue||(2,097,617)||(514,391)||(522,714)|
|Funds received from PPP loan||-||22,840||-|
|Principal elements of lease payments||(71,083)||(56,717)||(103,097)|
|Interest elements of lease payments||8,261||9,647||(19,730)|
|Net cash generated from financing activities||35,123,887||9,910,750||10,181,025|
|Net increase in cash and equivalents||31,914,538||7,228,993||4,320,796|
|Cash and equivalents at beginning of period||6,282,665||1,961,869||1,961,869|
|Cash and equivalents at end of period||38,197,203||9,190,862||6,282,665|