Corporate News

Final Results for the Year Ended 31 December 2021

18 May 2022

Notice of Annual General Meeting

 
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Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company with an investigational drug‑device combination product using hyperpolarised 129xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine announces its audited final results for the year ended 31 December 2021.

In addition, Polarean confirms that the Annual Report and Accounts for the year ended 31 December 2021, the Notice of the Annual General Meeting ("AGM") and a Form of Proxy are now available on the Company's website (http://www.polarean-ir.com/content/investors/annual-reports.asp) and will be posted to shareholders shortly.

Polarean's AGM will be held at 2500 Meridian Parkway, Suite 175, Durham, NC 27713, USA at 2 p.m. BST / 9 a.m. EST on Wednesday 29 June 2022.

Highlights

  • Raised £27 million (US$37.1 million) gross proceeds in an oversubscribed financing in April 2021, including continued support of strategic investors, Bracco Imaging S.p.A and Nukem Isotopes GmbH as well as institutional investor Amati AIM VCT plc, joined by several new UK and US institutional investors
  • Sale and installation of two new Polarean 9820 Xenon Polariser systems to each of the University of Texas MD Anderson Cancer Center and the University of British Columbia BC Children's Hospital
  • Appointment of Charles (“Chuck”) Osborne, Chief Financial Officer, to the Board
  • Publication of first peer-reviewed COVID-19 research using hyperpolarised xenon MRI to observe longer-term lung damage after COVID-19 infection by Professor Fergus Gleeson at the University of Oxford
  • Net cash of US$28.9 million as of 31 December 2021, which, based on strategic decisions, could finance the company into 2024

Post-period end

  • Successful re-submission of New Drug Application (NDA) to the FDA following the Complete Response Letter (CRL) received in October 2021, with an established user fee goal date of 30 September 2022
  • Further new research system orders from McMaster University in Ontario, Canada and Cincinnati Children’s Medical Center
  • Appointment of Frank Schulkes and Dan Brague to the Board as Non-Executive Directors
  • Appointment of Ken West as Non-Executive Chairman, following the retirement of Jonathan Allis
  • Research collaboration with Oxford University Hospitals NHS Trust for long-COVID

Richard Hullihen, CEO of Polarean, said: "In the first half of 2021 we completed our largest financing to date with an oversubscribed £27 million gross proceeds placing, subscription and open offer. We welcomed several significant new institutional investors and continued to receive excellent support from our existing strategic, institutional and retail investors.

 “We spent much of the year gearing towards our anticipated FDA approval, although the FDA confirmed in October that they were unable to approve the NDA in its current form due to some technical or manufacturing-related issues centred around the xenon hyperpolariser system. We worked hard with consultants and collaborators to thoroughly address the items raised and successfully resubmitted our application post-period end, in March 2022. We now have an established user fee goal date of 30 September 2022 and will continue to focus our efforts on building our commercial organisation to support a successful launch upon FDA approval.

 We continue to identify exciting opportunities in the areas of COVID-19, cardiology and pulmonary vascular disease and these prospects should expand the use of the Company’s technology in the future. Although the delay in FDA approval is disappointing, we are using this time to continue to explore potential future applications for our technology. On behalf of the Board and the whole Polarean team, I would like to extend my thanks to our shareholders for all their support and we look forward to a very positive year ahead.”  

 This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

 

Enquiries:

Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Officer Via Walbrook PR
Ken West, Chairman
 
Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)+44 (0)20 7710 7600
Nicholas Moore / Samira Essebiyea / William Palmer-Brown (Healthcare Investment Banking)  
Nick Adams / Fred Walsh (Corporate Broking)  
  
Walbrook PR Tel: +44 (0)20 7933 8780 or [email protected]
Anna Dunphy / Phillip Marriage Mob: +44 (0)7879 741 001 / +44 (0)7867 984 082
      

 

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of 30 September 2022.

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.

 

 

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Chairman’s Statement

I am pleased to report on a year of considerable progress for Polarean particularly in light of the ongoing global challenges. We have continued to build momentum in our strategy to advance our powerful Xenon MRI lung imaging technology towards commercialisation. The COVID pandemic, and the challenges that are growing with long COVID, have further accentuated the urgent global need for improved ways to diagnose and manage pulmonary disease. Polarean is poised to offer a solution to the gaps that exist with current diagnostic imaging to directly measure and visualise lung function.

Our efforts in 2021 focused on preparation for commercialisation, following the Company’s October 2020 New Drug Application (“NDA”) submission to the United States Food & Drug Administration (“FDA”). To fund these commercialisation efforts, in April 2021, the Company completed an oversubscribed £27 million placing, subscription and open offer. This financing round put the Company into a strong financial position and brought in several new top-tier investors into the Polarean shareholder base.

The market research and physician advisory boards that were conducted in 2021 thoroughly advanced our understanding of the unmet needs our technology seeks to address and highlighted the market opportunities that exist in several clinical applications at commercial launch. Through scientific engagement between our medical affairs team and pulmonary disease thought-leaders undertaken in 2021, it is clear that awareness, interest, and enthusiasm is building for the potential of hyperpolarised xenon MRI to improve the care of patients with pulmonary disease. The interest in Polarean’s technology is also growing amongst several pharmaceutical companies that are seeking novel approaches to use quantitative, functional lung imaging in the development of their investigational drugs. Finally, Polarean has also been in close contact with reimbursement entities in the US market, developing pathways to ensure that reimbursement for the use of Polarean’s products is established, and at a level that acceptable to insurers and providers

We were disappointed in early October 2021 to have received a Complete Response Letter (“CRL”) from the FDA in response to Polarean’s NDA submission. The Company worked diligently to comprehensively respond to the questions raised in the CRL, which were mostly technical and manufacturing related. The Company resubmitted the NDA to the FDA on 30 March 2022 and on 20 April 2022, the Company announced that the FDA had accepted the resubmission of the NDA and established a user fee goal date of 30 September 2022.

Our primary focus for the remainder of 2022 will be working with the FDA to obtain final approval for our drug-device combination product and continuing the planning and preparation for commercial launch. We are also looking forward to generating new clinical data evidence to support a strong value proposition and indication and geographical expansion in subsequent regulatory filings over the next several years.

On behalf of the Board, I thank the employees, stakeholders and shareholders for their support, without which none of this would have been possible.

 

 

Kenneth West
Non-Executive Chairman

17 May 2022

 

 

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Chief Executive Officer’s Statement

2021 – Year of Preparation and Response

We spent the first nine months of 2021 preparing for the launch of our drug-device combination product in anticipation of receiving FDA approval in the fourth quarter of 2021. On 5 October 2021, we were surprised to receive a CRL from the FDA, indicating that they were unable to approve the NDA in its current form. The CRL and subsequent Type A meeting with the FDA provided the Company with the list of issues that needed to be addressed to obtain approval. The issues were mostly technical or manufacturing-related in nature and centred around the xenon hyperpolariser system. The Company worked with its consultants and collaborators to address the items identified in the CRL. On 30 March 2022, the Company refiled the NDA with the FDA. The resubmission addressed the items identified in the CRL. On 20 April 2022, the Company announced that the FDA had accepted the resubmission of the NDA and established a user fee goal date of 30 September 2022, designating it Type 2.

The Opportunity

Pulmonary disease places a significant burden on the US and global healthcare systems. In addition, the COVID-19 pandemic has resulted in millions of additional patients who could potentially benefit from improvements in the quantitative assessment of pulmonary function via non-invasive imaging. The Company sees a tremendous opportunity to bring our technology’s quantitative, reproducible, non- invasive method for diagnostic and therapeutic guidance to medicine. Researchers around the world are receiving grants to study long COVID patients using the Company’s technologies. Promising preliminary results are already emerging and being published and we anticipate additional studies being published over the next 12 months. Researchers are currently conducting clinical trials and pharmaceutical company sponsored investigations in multiple areas of pulmonary disease using our technology. The Company continues to do market research and work with key opinion leaders through its advisory board process to refine and extend our understanding of current standards of care and refine the development of the healthcare economic analyses of our technology to support the adoption of hyperpolarised noble gas imaging by healthcare providers. The business plan continues to focus initially on addressing the high end of the US academic and teaching hospital market segment, which comprises approximately the top 1000 institutions nationally having coincident multiple Centres of Excellence in Pulmonary Medicine and Radiology. The combined addressable capital equipment market there for our products approaches US$500 million in equipment sales alone, with the consequent drug sales following, as laid out in recently published research. We also see a parallel opportunity supporting the pharmaceutical industry in improving the velocity and reducing the scale and cost of their pulmonary drug clinical trials by providing quantitative, reproducible image-based data.

Polarean continues to serve the medical imaging research market by providing xenon polarisers to enable functional MRI of the pulmonary system to institutions and researchers. This brings dynamic, reproducible, three-dimensional, high-resolution, regional, quantitative, image-based information to pulmonary physicians and researchers whose best alternative tool is spirometry, with its limitations in use for measurement of expired breath. We expanded our installed bases with two new polariser installations during 2021, including one at high profile academic research centre, MD Anderson.

Our Organisation

In anticipation of FDA approval, the Company has been involved in preparing the organisation for commercialisation of our products. The Company recently named Alexander Dusek as its Chief Commercial Officer. Mr. Dusek brings an extensive background in pharmaceutical industry commercialisation and is building our commercial organisation to support a successful launch upon FDA approval.

Our Operations

In 2021, the Company focused on working with its drug and system contract manufacturing partners to ensure that they are prepared for the launch of the Company’s product. In addition, we made planned advances in our quality systems and engineering infrastructure as we move toward maturing in our new regulated environment.

During the year, we completed installations of two model 9820 xenon polariser systems at BC Children’s Hospital, Vancouver BC, and at the University of Texas MD Anderson Cancer Center, to support their pulmonary research programmes.

R&D

We continued to invest in our intellectual property portfolio and future development of our technology. Intellectual property continues to be developed in the areas of gas exchange and pulmonary vascular disease. Our group has continued to push the design of the polariser systems forward. We have also made key advances in exciting new display and analysis software focused on providing an intuitive, colour encoded three-dimensional display for use across all stakeholders in the healthcare process focused on providing care to pulmonary patients.

Financials

Sales for 2021 were below our original expectations, as we did not receive FDA approval in the final quarter as anticipated in the plan. We were able to adjust our spending plans following receipt of the CRL from the FDA, which allowed us to finish 2021 with a higher than anticipated cash balance of US$28.9 million. We continued to sell our polariser systems into the research market and completed two installations during 2021. The financing we completed in the first half of 2021 has put the Company in a solid financial position with the ability to fund the Company well into 2023.

Advisers

The Company appointed Stifel as joint broker in December 2020 and followed that up by appointing them as the Company’s nominated adviser and sole broker early in 2021. Stifel guided the Company through an oversubscribed round of financing, securing important new and larger funds participation in the first half of 2021 that allowed the Company to prepare for the anticipated US launch of its product.

2022 and Beyond

We spent the first quarter of 2022 finalising our NDA resubmission focusing on execution of near-term objectives. We announced on 20 April 2022 that the FDA had accepted the resubmission of the NDA as a complete response and has established a user fee goal date of 30 September 2022. In the meantime, we continue to sell our systems to the research market, including the recently announced order and installation from McMaster University in Canada, and an order for an additional system at Cincinnati Children’s Hospital Medical Center.

We continue to identify exciting opportunities in the areas of long COVID, cardiology and pulmonary vascular disease and these prospects should expand the use of the Company’s technology in the future. We recently announced a research collaboration in long COVID with Oxford University Hospitals NHS Trust, whereby we will evaluate the underlying causes of persistent breathlessness in patients with long COVID using our xenon polariser. We are utilising the delay in obtaining FDA approval to work on the commercialisation and launch programmes and explore initiation of follow-on trials for potential future applications of our technology. We have begun evaluation of geographic market exploration and expansion, and the pursuit of early engagement with respiratory drug developers as we develop scale sufficient to prove our value proposition with regard to reducing the costs of their drug development process.

Polarean has a dedicated team of employees, consultants and advisers working to bring our much- needed technology to the healthcare market.

 

Richard Hullihen
Chief Executive Officer

 

17 May 2022

 

 

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Consolidated Statement of Comprehensive Income

  2021  2020
 Notes US$  US$
Revenue 4 1,185,427  1,056,766
Cost of sales  (677,402)  (346,300)
Gross profit  508,025  710,466
     
Administrative expenses  (6,517,396)  (5,049,246)
Depreciation 11 (177,349)  (150,224)
Amortisation 12 (757,016)  (734,058)
Selling and distribution expenses  (5,557,829)  (917,783)
Share-based payment expense 19 (1,814,882)  (474,716)
Total administrative expenses  (14,824,472)  (7,326,027)
Operating loss 6 (14,316,447)  (6,615,562)
Finance income 7 321,544  100,769
Finance expense 7 (21,101)  (19,730)
Loss before tax  (14,016,004)  (6,534,523)
Taxation 10 -  -
Loss for the year and total other comprehensive expense  (14,016,004)  (6,534,523)
     
Loss per share     
Basic and diluted (US$) 9 (0.071)  (0.044)

 

The results reflected above relate to continuing activities.

 

There are no items of Other Comprehensive Income (“OCI”) for the year other than the loss above and therefore no separate statement of other comprehensive income has been presented.

 

 

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Consolidated Statement of Financial Position

 Notes 20212020
  US$US$
ASSETS    
Non-current assets    
Property, plant and equipment 11 634,779 271,264
Intangible assets 12 2,193,843 2,810,694
Right-of-use assets 24 422,816 184,213
Trade and other receivables 14 5,539 5,539
  3,256,977 3,271,710
Current assets    
Inventories 15 1,426,810 977,924
Trade and other receivables 14 970,968 348,067
Cash and cash equivalents 16 28,874,908 6,282,665
  31,272,686 7,608,656
TOTAL ASSETS  34,529,663 10,880,366
    
EQUITY AND LIABILITIES    
Equity attributable to holders of the parent  
Share capital 17 101,642 78,200
Share premium 18 59,022,919 23,840,571
Group re-organisation reserve 18 7,813,337 7,813,337
Share-based payment reserve 19 3,660,332 1,845,450
Accumulated losses 18 (38,860,208) (24,844,204)
  31,738,022 8,733,354
    
    
Non-current liabilities    
Deferred income 21 145,747 219,954
Lease liability 24 358,837 91,609
Contingent consideration 20 316,000 316,000
 820,584 627,563
    
Current liabilities    
Trade and other payables 22 1,731,114 1,348,867
Lease liability 24 130,949 129,819
Deferred income 21 108,994 40,763
  1,971,057 1,519,449
TOTAL EQUITY AND LIABILITIES  34,529,663 10,880,366

 

These Financial Statements were approved and authorised for issue by the Board of Directors on 17 May 2022 and were signed on its behalf by:

 

 

Kenneth West
Non-Executive Chairman 

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Company Statement of Financial Position

 Notes 20212020
  US$US$
ASSETS    
Non-current assets    
Investment in subsidiary 13 58,180,314 24,735,727
  58,180,314 24,735,727
Current assets    
Trade and other receivables 14 22,410 61,304
Cash and cash equivalents 16 2,454,491 911,271
  2,476,901 972,575
TOTAL ASSETS  60,657,215 25,708,302
    
EQUITY AND LIABILITIES    
Equity attributable to holders of the parent  
Share capital 17 101,642 78,200
Share premium 18 59,022,919 23,840,571
Merger reserve 18 4,322,527 4,322,527
Share-based payment reserve 19 3,355,301 1,540,419
Accumulated losses 18 (6,251,190) (4,122,345)
  60,551,199 25,659,372
    
Current liabilities    
Trade and other payables 22 106,016 48,930 class
  106,016 48,930
TOTAL EQUITY AND LIABILITIES  60,657,215 25,708,302

 

For the year under review, the amount due from subsidiary undertaking is regarded as net investment and is therefore reclassified from trade and other receivable to investment in subsidiary, and their respective comparatives were also restated.

As permitted by section 408 of the Companies Act 2006, no separate statement of Comprehensive Income is presented in respect of the parent Company. The loss for the financial year dealt with in the financial statements of the parent Company was US$2,128,845         (2020: US$908,895).

These financial statements were approved and authorised for issue by the Board of Directors on 17 May 2022 and were signed on its behalf by:

Kenneth West
Non-Executive Chairman

 

 

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Consolidated Statement of Changes in Equity

 Share capital
US$
Share premium
US$
Share-based payment reserve
US$
Group
re-organisation reserve
US$
Accumulated losses
US$
Total equity
US$
As at 1 January 2020 55,776 13,659,912 1,370,7347,813,337 (18,309,681) 4,590,078
Comprehensive income       
Loss for the year - - - - (6,534,523) (6,534,523)
Transactions with owners       
Issue of shares 22,424 10,703,373 - - - 10,725,797
Share issue costs - (522,714) - - - (522,714)
Share-based payment expense - - 474,716 - - 414,716
As at 31 December 2020 (audited) 78,200 23,840,571 1,845,450 7,813,337 (24,844,204) 8,733,354
Comprehensive income
Loss for the year - - - - (14,016,004) (14,016,004)
Transactions with owners       
Issue of shares 23,442 37,284,454 - - - 37,307,896
Share issue costs - (2,102,106) - - - (2,102,106)
Share-based payment expense - - 1,814,882 - - 1,814,882
As at 31 December 2021 101,642 59,022,919 3,660,332 7,813,337 (38,860,208) 31,738,022

 

Company Statement of Changes in Equity

 Share capital
US$
Share premium
US$
Share-based payment reserve
US$
Merger reserve
US$
Accumulated losses
US$
Total equity
US$
As at 1 January 2020 55,776 13,659,912 1,065,703 4,322,527 (3,213,450) 15,890,468
Comprehensive income       
Loss for the year - - - - (908,895) (908,895)
Transactions with owners       
Issue of shares 22,424 10,703,373 - - - 10,725,797
Share issue costs - (522,714) - - - (522,714)
Share-based payment expense - - 474,716 - - 474,716
As at 31 December 202078,200 23,840,571 1,540,419 4,322,527 (4,122,345) 25,659,372
Comprehensive income       
Loss for the year - - - - (2,128,845) (2,128,845)
Transactions with owners       
Issue of shares 23,442 37,284,454 - - - 37,307,896
Share issue costs - (2,102,106) - - - (2,102,106)
Share-based payment expense - - 1,814,882 - - 1,814,882
As at 31 December 2021101,642 59,022,919 3,355,301 4,322,527 (6,251,190) 60,551,199

 

 

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Consolidated Statement of Cash Flows

  2021
US$
2020
US$
Cash flows from operating activities   
 (14,016,004) (6,534,522)
Loss before tax   
Adjustments for non-cash/non-operating items:   
Depreciation of plant and equipment 177,349 150,224
Amortisation of intangible assets and right-of use-assets 757,015 734,058
Loss on disposal of property, plant and equipment 590 -
Loss on remeasurement of right-of-use assets 11,660 -
Share-based payment expense 1,814,882 474,716
Finance expense 21,101 19,730
Finance income (321,544) (100,769)
Operating cash outflows before movements in working capital (11,554,95) (5,256,563)
Increase in inventories (448,886) (423,093)
(Increase)/decrease in trade and other receivables (622,901) 288,096
Increase/(decrease) in trade and other payables 382,247 (424,714)
(Decrease)/increase in deferred income (5,976) 21,576
Net cash used in operations (12,250,467) (5,794,698)
Cash flows from investing activities   
Purchase of plant and equipment (541,454) (65,531)
Net cash used in investing activities (541,454) (65,531)
Cash flows from financing activities   
Issue of shares 37,307,896 10,725,797
Cost of issue (2,102,106) (522,714)
Interest paid on lease liabilities ­(21,101) (19,730)
Interest received 321,544 100,769
Principal elements of lease payments (122,069) (103,097)
Net cash generated by financing activities 35,384,164 10,181,025
 
Net increase in cash and cash equivalents 22,592,243 4,320,796
Cash and cash equivalents at the beginning of year 6,282,665 1,961,869
Cash and cash equivalents at end of year 28,874,908 6,282,665
    

 

Company Statement of Cash Flows

 Year ended
31 December
2021
US$
Year ended
31 December
2020
US$
Cash flows from operating activities   
Loss before tax (2,128,845) (908,895)
Adjustments for non-cash/non-operating items:   
Share-based payment expense 1,814,882 474,716
Interest received (319,564) (100,358)
Operating cash outflows before movements in working capital (633,527) (534,537)
Increase in trade and other receivables 38,894 42,372
Increase/(decrease) in trade and other payables 57,086 (4,068)
Net cash used by operations (537,547) (496,233)
Cash flows from financing activities   
Issue of shares 37,307,896 10,725,797
Cost of issue (2,102,106) (522,714)
Interest received 319,564 100,358
Loans to the Subsidiary (33,444,587) (8,952,702)
Net cash generated by financing activities 2,080,767 1,350,739
  
Increase in cash and cash equivalents1,543,220 848,506
Cash and cash equivalents at the beginning of period911,271 56,765
Cash and cash equivalents at end of period2,454,491 911,271

 

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Notes on Financial Statements

The notes are available in the printable pdf of the results. To download it, please click here.

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