24 September 2019
Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary drug-device combination product for the magnetic resonance imaging (MRI) market, announces its unaudited interim results for the six months ended 30 June 2019.
Statement of Comprehensive Income
Statement of Financial Position
Statement of Changes in Equity
Cash Flow Statement
- Significant enrolment in Phase III FDA clinical trials (the “Clinical Trials”) as Clinical Trials near completion
- Third trial site added at University of Cincinnati, in addition to Duke University and the University of Virginia, to improve enrolment rates for its Clinical Trials
- Three new orders for Polarean’s 9820 Xenon Polariser system from the University of British Columbia, The Hospital for Sick Children (“SickKids”) in Toronto and the University of Kansas.
- Third tranche of US$1m confirmed from US$3m Small Business Innovation Research (“SBIR”) grant
- Second London Investor Symposium completed in June 2019
- Appointment of Charles (“Chuck”) Osborne as the Company’s new Chief Financial Officer
- Net cash of US$1.28m at 30 June 2019
- Raised £2.1m (gross) via a placing of 11,666,667 ordinary shares at a placing price of 18p per share in July 2019
- Enrolment for the Clinical Trials has now passed 98% in the lung transplant pathway and 87% in the lung lobe resection pathway, with a total of 80 patients targeted for enrolment
- Delivered and installed a 9820 Xenon Polariser system at SickKids
- Number of Xenon Polariser systems installed or on order is 25
Richard Hullihen, CEO of Polarean, commented: "Our continued global engagement with the expanding base of clinicians and researchers, while extending our technology and discovering new techniques, reinforces our belief that pulmonary medicine patients and their doctors deserve the benefits of our unique three-dimensional, non-invasive, reproducible hyperpolarised xenon gas imaging technology. We have now entered a crucial period for the Company as the Clinical Trials near completion, with the top-line results of the Clinical Trials expected before the end of 2019. We remain confident and excited for the future of Polarean and are grateful to our shareholders and stakeholders for their continued support."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
|Polarean Imaging plc||www.polarean.com / www.polarean-ir.com|
|Richard Hullihen, Chief Executive Officer||Via Walbrook PR|
|Richard Morgan, Chairman|
|SP Angel Corporate Finance LLP||Tel: +44 (0)20 3470 0470|
|David Hignell / Lindsay Mair / Jamie Spotswood (Corporate Finance)
Vadim Alexandre / Rob Rees (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, medical drug-device combination companies operating in the high resolution functional magnetic resonance imaging market.
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 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. Xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.
The six month period ending 30 June 2019 has seen Polarean make substantial progress towards its goal of completing the Clinical Trials for the Company’s medical drug-device combination.
The first half of the financial year was committed to critically analysing the performance of the Clinical Trial sites and their protocols and processes for recruitment as the Clinical Trials progressed and enrolment rates increased.Despite having skilled academic site clinical trial organizations and contract research organizations (CROs), there is always a period of discovery and correction associated with any first of type trial, and we found and fixed several restrictions to our recruitment rates, working collaboratively with our CROs and academic sites.
Our financial performance, with sales being made on a research-use-only basis to academic institutions in the US and Europe, remains in-line with management expectations. Revenues for the first half decreased from US$1.0m to US$0.4m, with gross profits US $0.32m (H1 2018: US$0.75m). This is primarily attributable to the timing of polariser sales. We received three high value polariser orders, during H1 2019, one of which was installed during September 2019. The other two polarisers are anticipated to be delivered during Q4 2019. Gross operating margins remain at over 50%. Administrative Expenses were flat for the period. Our overall loss before tax increased to US$3.4m from US$2.7m in the same comparable period, due to the lower revenue during the period. Cash controls within the business remain robust and as at 30 June 2019 we held US US$1.28m in net cash or cash equivalents.
The Company held its second Investor Symposium in London on 12 June 2019. Attendance was significantly higher than it was at our first investor symposium which we held in June 2018, and the feedback from the 2019 symposium was positive. We conducted a review of the latest technology breakthroughs, as well as presentations by Key Opinion Leaders from two sites: Dr. Jason Woods from Cincinnati Chilldren’s Hospital speaking on Cystic Fibrosis, and Dr. Sudarshan Rajagopal from Duke University speaking on pulmonary vascular disease. The video of the symposium can be viewed here: http://www.polarean-ir.com/content/investors/videos.asp
Post-period end events
Placing to raise £2.1m (gross) at 18p completed
On the 22 July 2019 Polarean announced the completion of a placing to raise an additional £2.1m (gross) at a placing price of 18 pence per share in response to strong demand from institutional and EIS/VCT investors. We are encouraged with the support shown by new and existing shareholders and these additional funds will further support our Clinical Trials in the US, preparation of our New Drug Application (“NDA”) for submission to the US Food and Drug Administration (“FDA”), preparations for commercial launch and the improvements we continue to make to our polarisers.
Delivery of Xenon Polarisers
Whilst we seek clinical approval for our medical drug-device combination we continue to expand our installed base of systems through additional sales of research units to academic institutions.
Post-period end, we delivered and installed a new system at the SickKids Hospital Toronto. This is an additional system for SickKids who is a long-term collaborator and customer of the Company.
In February and July 2019, we received orders for additional Polarean 9820 Polariser systems. We anticipate shipping these two systems to the customers in the second half of 2019. The number of systems installed or on order is currently 25*.
* Inadvertently reported as 24 in the RNS dated 10 September 2019 which omitted the system ordered by KUMC as per the RNS dated 11 July 2019.
We continue to demonstrate and reinforce our belief that Polarean’s technology can be a tremendous benefit to patients and a powerful new tool for clinicians in discovering and demonstrating 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 upside potential of our technology. There are 40 clinical trials currently ongoing into the use of 129Xe MRI accruing to the FDA website.
The burden of pulmonary disease in the USA is approximately US$150bn, with pulmonary disease widespread and growing, affecting nearly 40 million Americans. Given the limitations of existing methods of diagnosis and lung disease monitoring, we believe that there is a significant unmet need for non-invasive, quantitative, and cost-effective image-based diagnosis technology. We believe that our unique medical drug-device combination utilizing 129Xe offers the ideal solution for improving pulmonary disease diagnosis and we are confident that this will be borne out during the Company’s Clinical Trials.
Chief Executive Officer
23 September 2019
|Note||6 months ended 30.6.19 US$||6 months ended 30.6.18 US$||12 months ended 31.12.18 US$|
|Cost of sales||(75,185)||(279,455)||(633,463)|
|Selling and distribution expenses||(147,821)||(20,998)||(31,766)|
|Share based payment expense||(139,886)||(87,400)||(251,790)|
|Loss from operations||(3,378,222)||(2,780,764)||(5,266,788)|
|Finance expense||(22,356) 356)||(52,654)||(188,055)|
|Loss on ordinary activities before taxation||4||(3,400,304)||(2,833,391)||(5,454,659)|
|Loss and total other comprehensive expense||(3,400,304)||(2,833,391)||(5,454,659)|
|Basic and fully diluted loss per share (US$)||4||(0.034)||(0.057)||(0.078)|
|As at 30.6.19US$||As at 30.6.18 US$||As at 31.12.18 US$|
|Property, plant and equipment||13,091||23,403||17,752|
|Trade and other receivables||5,539||12,536||12,539|
|Trade and other receivables||1,094,988||1,148,306||4,226,585|
|Cash and cash equivalents||1,277,195||1,374,866||875,601|
|Group reorganisation reserve||7,813,337||7,813,337||7,813,337|
|Share-based payment reserve||1,218,221||913,945||1,078,335|
|Trade and other payables||1,604,792||1,908,079||1,590,482|
|Total equity and liabilities||7,491,598||7,981,277||9,828,656|
|Balance as at 31 December 2017 (audited)||23,291||1,448,037||7,813,337||87,305||826,545||(6,758,108)||3,440,407|
|Loss and total comprehensive income for the period||-||-||
|Transaction with owners|
|Issue of shares||13,105||5,124,897||-||(87,305)||-||-||5,050,697|
|Share issue costs||-||(140,122)||-||-||-||-||(140,122)|
|Balance as at 30 June 2018 (unaudited)||36,396||6,432,812||7,813,337||-||913,945||(9,591,499)||5,604,991|
|Loss and total comprehensive income for the period||-||-||
|Transaction with owners|
|Issue of shares||13,031||5,036,577||-||-||-||-||5,049,608|
|Share issue costs||-||(406,314)||-||-||-||-||(406,314)|
|Balance as at 31 December 2018 (audited)||49,427||11,063,075||7,813,337||-||1,078,335||(12,212,767)||7,791,407|
|Change in accounting policy||-||-||-||-||-||(6,922)||(6,922)|
|Restated total equity at 1 January 2019||49,427||11,063,075||7,813,337||-||1,078,335||(12,219,689)||7,784,485|
|Loss and total comprehensive income for the period||-||-||-||-||-||(3,400,304)||(3,400,304)|
|Transaction with owners|
|Issue of shares||340||137,386||-||-||-||-||137,726|
|Balance as at 30 June 2019 (unaudited)||49,767||11,200,461||7,813,337||-||1,218,221||(15,619,993)||4,661,793|
|6 months ended 30.6.19
|6 months ended 30.6.18
|12 months ended
|Cash flows from operating activities|
|Loss for the period before taxation||(3,400,304)||(2,833,391)||(5,454,659)|
|Adjustments for non-cash/non-operating items:|
|Depreciation of plant and equipment||4,661||4,489||10,140|
|Amortisation of intangible assets||341,937||308,426||616,852|
|Share based compensation||139,886||87,400||251,790|
|Changes in working capital:|
|Increase in inventories||(581,257)||(419,482)||(1,921)|
|Increase in trade and other receivables||(301,448)||(659,448)||(69,517)|
|(Decrease)/increase/ in trade and other payables||36,955||10,026||(315,894)|
|Increase/(decrease) in deferred revenue||617,575||(24,233)||98,992|
|Net cash flows used from operating activities||(3,119,913)||(3,473,586)||(4,676,346)|
|Cash flows from investing activities|
|Purchase of plant and equipment||-||(6,551)||(6,551)|
|Net cash used in investing activities||-||(6,551)||(6,551)|
|Cash flows from financing activities|
|Repayment of loans||
|Issue of shares||3,577,509||4,063,539||5,093,775|
|Principal elements of lease payments||(42,793)||-||-|
|Interest elements of lease payments||8,873||-||-|
|Net cash generated from financing activities||3,521,507||3,894,786||4,598,281|
|Net increase in cash and equivalents||401,594||414,649||(84,616)|
|Cash and equivalents at beginning of period||875,601||960,217||960,217|
|Cash and equivalents at end of period||1,277,195||1,374,866||875,601|
The notes to the financial statement are available in the PDF download.