Corporate News

2021

Half-year Report

Sep 30, 2020, 06:03 AM by felicity.hopkins ICOM

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary investigational drug-device combination diagnostic for magnetic resonance imaging (“MRI”), announces its unaudited interim results for the six months ended 30 June 2020.

CEO Statement
Statement of Comprehensive Income
Statement of Financial Position
Statement of Changes in Equity
Cash Flow Statement
Download

To view a full version of the results in 
PDF format click here

Highlights

  • Positive results from Phase III trials (the “Clinical Trials”) announced in January 2020
  • Raised gross proceeds of £8.4m in April 2020, which included a £2.2m subscription from new strategic investor Bracco Imaging S.p.A. (“Bracco”)
  • Appointment of former NED Jonathan Allis as Chairman in February 2020
  • Appointment of Cyrille Petit as Non-Executive Director and representative of Bracco in June 2020
  • Net cash of US$9.2m as of 30 June 2020

Post-period end

  • Significant progress toward submission of New Drug Application (“NDA”)
    • the United States Food and Drug Administration (“FDA”) on 28 September 2020
    • NDA to be submitted in early October 2020
  • Presentation of data at the American Thoracic Society and the International Society for Magnetic Resonance in Medicine virtual conferences
  • Installed a 9820 Xenon Polariser system at University of Kansas Medical Center (“KU Medical Center”)
  • Government COVID-19-related grants are being applied for and received by our current device users, including a recent award for a multi-center initiative coordinated by Western Ontario Professor Grace Parraga PhD to better understand the long-term effects of COVID-19 using hyperpolarised 129Xe MRI in combination with computed tomography (CT)

Richard Hullihen, CEO of Polarean, commented: “During the period under review, Polarean achieved one of its most important milestones to date, the positive readout from our Phase III Clinical Trials. We subsequently undertook an £8.4m fundraising and welcomed our new strategic investor Bracco to our share register, alongside several new institutional investors. We are also grateful for the continued support we received from our existing long-term investors and partners. The installation of new polarisers has continued and users of our systems are publishing research at an increased rate, expanding and deepening the knowledge base of the use of hyperpolarised 129Xe in pulmonary medicine, while further validating Polarean’s technology. We look forward to providing our shareholders with updates regarding further progress and specifically the imminent submission of the Company’s NDA to the FDA.”

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

 

Enquiries:

Polarean Imaging plcwww.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive OfficerVia Walbrook PR
Jonathan Allis, Chairman 
  
SP Angel Corporate Finance LLPTel: +44 (0)20 3470 0470
David Hignell / Soltan Tagiev (Corporate Finance) 
Vadim Alexandre / Rob Rees (Corporate Broking)  
  
Walbrook PR Tel: +44 (0)20 7933 8780 or [email protected]
Paul McManus / Anna DunphyMob: +44 (0)7980 541 893 /
+44 (0)7876 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 medical 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 Group operates in an area of significant unmet medical need and the Group's technology provides a novel 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.

The Group also develops high performance MRI radiofrequency (RF) coils which are a required component for imaging 129Xe in the MRI system. The development of these coils by the Group facilitates the adoption of the Xenon technology by providing application-specific RF coils which optimise the imaging of 129Xe in MRI equipment for use as a medical diagnostic as well as a method of monitoring the efficacy of therapeutic intervention.

 

CEO Statement

Introduction
The six month period ending 30 June 2020 has seen Polarean make substantial progress towards its goal of seeking FDA approval for the Company’s drug-device combination.  After successfully completing two Phase III Clinical Trials in Q4 2019, the Company announced positive top line results of these Clinical Trials on 29 January 2020. During the first half of 2020, the Company performed the post trial in depth analysis of the results of the Clinical Trials and initiated work associated with the construction of both the drug and device components of our NDA submission.

Despite the challenging market conditions in the first half of 2020, the Company closed a financing that resulted in gross proceeds of US$10.4m (£8.4m). This financing included a new strategic investor, Bracco Imaging S.p.A., several new institutional investors and the continued support of previous VCT and EIS investors. We are encouraged with the support shown by new and existing shareholders and these additional funds will further support our preparation of our NDA for submission to the FDA, focus on preparations for commercial launch and continue development of our polariser system.

Also, during the period, former NED Jonathan Allis was appointed Chairman of Polarean after the sale of his former company, Blue Earth Diagnostics, to Bracco. We also welcomed Cyrille Petit to the Board, as a result of the Bracco investment.

Results overview
Group revenues for the first half were US$0.3m (2019: US$0.4m) and were largely derived from our collaboration with the University of Cincinnati where work under our SBIR grant has been completed.  We continue to sell our polariser systems on a research-use-only basis to academic institutions in the US, Canada and Europe. Due to COVID-19, we were unable to complete the installation of a polariser system we had delivered to KU Medical Center during December 2019. The system installation completed recently as per the Company’s announcement on 18 September 2020. Operating expenses for H1 2020 (US$3.4m) were flat compared with H1 2019 (US$3.4m), as Administrative Expenses (H1 2020 US$2.7m, H1 2019 US $3.1m) decreased after we completed the Clinical Trials and Selling and Distribution Expenses (H1 2020 US$0.4m, H1 2019 US $0.1m) increased as we began preparations for commercial launch. During H1 2020, the Company received a US$0.3m forgivable loan under the US Paycheck Protection Program (“PPP”), which was recognised as Finance Income. Our overall loss before tax decreased from US$3.4m to US$3.2m in the same comparable period, due to the PPP proceeds. The Company completed the £8.4m fundraise during H1 2020 via the issue of new equity and as at 30 June 2020 we held US US$9.2m in net cash or cash equivalents.

Post-period end events

Presentation at Medical Conferences and Studies Utilising our Technology
The Company’s technology was prominent at the American Thoracic Society and International Society of Magnetic Resonance in Medicine virtual conferences during August 2020. Over 40 abstracts related to the use of hyperpolarised 129Xe were presented at the two conferences, including the Company’s Clinical Trial results. The content of our publications and those of our customers, along with our participation is available on our website at www.polarean.com . The users of our polarisers continue to expand and document the applications of our technology across the spectrum of pulmonary disease.

The “129Xe MRI Clinical Trials Consortium” continues to discuss the application of our technology to the case of post infection COVID-19 patients to assess the long-term effects and case management of these patients.  Investigator-initiated government research grants have been submitted to study the use of our technology to assess the long-term effects of COVID-19 post infection in patients. Some of these grants have been awarded and COVID-19-related clinical research has begun.

Installation 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. We recently completed the installation of a new system at the KU Medical Center, which is starting up a research programme under the guidance of a veteran researcher in the field of hyperpolarised 129Xe imaging.

Researchers continue to apply for and receive grants to purchase our polariser systems. We are in discussions with several potential customers and anticipate additional orders during calendar year 2020. The number of systems currently installed is 23.

NDA Submission
We have continued to compile the components of the NDA submission. On 28 September 2020, the Company was granted a Small Business Waiver of Human Drug Application Fee (the “Waiver”) by the FDA. The Waiver exempts the Company from having to pay the US$2.9m filing fee for our NDA submission. We anticipate submitting our NDA to the FDA in early October 2020.

Outlook
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. There are currently 40 clinical trials ongoing into the use of 129Xe MRI according to the FDA website.

The burden of pulmonary disease in the USA is approximately US$150bn and is widespread and growing, affecting nearly 40 million Americans. Given the limitations of existing methods of diagnosis and lung disease monitoring, we estimate 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 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.

 

Richard Hullihen
Chief Executive Officer

30 September 2020

 

Consolidated unaudited statement of comprehensive income
for the six months ended 30 June 2020

  Unaudited Unaudited Audited
  6 months
ended
30.6.20
US$
 6 months
ended
30.6.19
US$
 12 months
ended
31.12.19
US$
 Note     
       
Revenue 327,896 399,639 2,301,093
Cost of sales (41,387) (75,185) (925,612)
Gross profit 286,509 324,454 1,375,481
       
Administrative expenses (2,724,411) (3,068,371) (6,010,119)
Depreciation (73,204) (4,661) (63,121)
Amortisation (359,677) (341,937) (683,873)
Selling and distribution expenses (351,754) (147,821) (324,791)
Share based payment expense (213,906)  (139,886) (305,747)
Loss from operations (3,436,443) (3,378,222) (6,012,170)
       
Finance expense (9,647) (22,356) (91,678)
Finance income 267,155 274 508
Loss on ordinary activities before taxation3(3,178,935) (3,400,304)  (6,103,340)
       
Taxation - -  -
Loss and total other comprehensive expense (3,178,935) (3,400,304)  (6,103,340)
Basic and fully diluted loss per share (US$)3(0.023) (0.034)  (0.057)

 

Consolidated unaudited statement of financial position
at 30 June 2020

  Unaudited Unaudited Audited
  As at
30.6.20
US$
 As at
30.6.19
US$
 As at
31.12.19
US$
AssetsNote     
Non-current assets      
Property, plant and equipment 312,287 13,091 355,958
Intangible assets 3,119,120 3,735,973 3,427,547
Right-of-use asset 224,414 131,773 98,263
Trade and other receivables 5,539 5,539 5,539
  3,661,360 3,886,376 3,887,307
Current assets      
Inventories 950,674  1,233,039  554,211
Trade and other receivables 522,625 1,094,988 636,783
Cash and cash equivalents 9,190,862 1,277,195 1,961,869
  10,664,161 3,605,222 3,152,863
Total assets 14,325,521 7,491,598 7,040,170
       
Equity      
Share capital477,518 49,767 55,776
Share premium 23,573,058 11,200,461 13,659,912
Group reorganisation reserve 7,813,337 7,813,337 7,813,337
Share-based payment reserve 1,584,640 1,218,221 1,370,734
Accumulated losses  (21,488,616) (15,619,993) (18,309,681)
Total equity 11,559,937 4,661,793 4,590,078
       
Liabilities      
Non-current liabilities      
Deferred income 192,817 87,029 192,817
Lease liability 5149,487 83,168 50,455
Contingent consideration 316,000 316,000 316,000
  658,304 486,197 559,272
Current liabilities      
Trade and other payables 1,985,828 1,604,792 1,773,582
Lease liability 5102,213 82,716 70,914
Deferred income 19,239 656,100 46,324
  2,107,280 2,343,608 1,890,820
Total equity and liabilities 14,325,521 7,491,598 7,040,170

 

Consolidated unaudited statement of changes in equity
at 30 June 2020

 Share
capital
Share
premium
Group
re-
organisation
Share-based
payment
reserve
Accumulated
losses
Total
equity
Balance as at 31 December 2018 (audited)49,42711,063,0757,813,3371,078,335(12,212,767)7,791,407
       
Change in accounting policy - - - - (6,922) (6,922)
Restated total equity at 1 January 201949,42711,063,0757,813,3371,078,335(12,219,689)7,784,485
       
Loss and total comprehensive income for the period----(3,400,304)(3,400,304)
Issue of shares340137,386---137,726
Share-based payments---139,886-139,886
Balance as at 30 June 2019 (unaudited)49,76711,200,4617,813,3371,218,221(15,619,993)4,661,793
Comprehensive income       
Share based payment – lapsed share options---(13,348)13,348-
Loss and total comprehensive income for the period----(2,703,036)(2,703,036)
Transaction with owners      
Issue of shares6,0092,618,903---2,624,912
Share issue costs-(159,452)---(159,452)
Share-based payments---165,861-165,861
Balance as at 31 December 2019 (audited)55,77613,659,9127,813,3371,370,734(18,309,681)4,590,078
Loss and total comprehensive income for the period----(3,178,935)(3,178,935)
Issue of shares21,74210,427,537---10,449,279
Share issue costs-(514,391)---(514,391)
Share-based payments---213,906-213,906
Balance as at 30 June 2020 (unaudited) 77,51823,573,0587,813,3371,584,640(21,488,616)11,559,937

 

Consolidated unaudited cash flow statement
for the six months ended 30 June 2020

  UnauditedUnauditedAudited
  6 months
ended
30.6.20
US$
6 months
ended
30.6.19
US$
12 months
ended
31.12.19
US$
Cash flows from operating activities    
Loss for the period before taxation (3,178,935) (3,400,304) (6,103,340)
Adjustments for non-cash/non-operating items:    
Depreciation of plant and equipment 73,2044,661 63,121
Amortisation of intangible assets 359,677341,937 683,873
Share based compensation 213,906 139,886 305,747
Interest paid -22,35691,678
Interest received (92)(274) (508)
  (2,532,240) (2,891,738)(4,959,429)
Changes in working capital:    
Increase in inventories (396,462) (581,257)(97,570)
Increase in trade and other receivables 114,157 (301,448) (14,737)
(Decrease)/increase in trade and other payables 189,40736,955 (285,074)
Increase/(decrease) in deferred revenue (27,085) 617,575 595,961
Net cash flows used from operating activities (2,652,223) (3,119,913) (4,565,709)
     
Cash flows from investing activities    
Purchase of plant and equipment (29,534)- (401,327)
Net cash used in investing activities (29,534)- (401,327)
     
Cash flows from financing activities     
Issue of shares 10,449,279 3,577,509 6,373,919
Cost of issue (514,391) (159,452)
Interest paid - (22,356) -
Interest received 92 274 508
Funds received from PPP loan 22,840--
Principal elements of lease payments (56,717)(42,793)(69,993)
Interest elements of lease payments 9,6478,873(91,678)
Net cash generated from financing activities 9,910,750 3,521,5076,053,304
     
Net increase in cash and equivalents 7,228,993404,594(1,086,268)
Cash and equivalents at beginning of period 1,961,869 875,601 875,601
Cash and equivalents at end of period 9,190,8621,277,1951,961,869

2020

Half-year Report

Sep 30, 2020, 06:03 AM by felicity.hopkins ICOM

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary investigational drug-device combination diagnostic for magnetic resonance imaging (“MRI”), announces its unaudited interim results for the six months ended 30 June 2020.

CEO Statement
Statement of Comprehensive Income
Statement of Financial Position
Statement of Changes in Equity
Cash Flow Statement
Download

To view a full version of the results in 
PDF format click here

Highlights

  • Positive results from Phase III trials (the “Clinical Trials”) announced in January 2020
  • Raised gross proceeds of £8.4m in April 2020, which included a £2.2m subscription from new strategic investor Bracco Imaging S.p.A. (“Bracco”)
  • Appointment of former NED Jonathan Allis as Chairman in February 2020
  • Appointment of Cyrille Petit as Non-Executive Director and representative of Bracco in June 2020
  • Net cash of US$9.2m as of 30 June 2020

Post-period end

  • Significant progress toward submission of New Drug Application (“NDA”)
    • the United States Food and Drug Administration (“FDA”) on 28 September 2020
    • NDA to be submitted in early October 2020
  • Presentation of data at the American Thoracic Society and the International Society for Magnetic Resonance in Medicine virtual conferences
  • Installed a 9820 Xenon Polariser system at University of Kansas Medical Center (“KU Medical Center”)
  • Government COVID-19-related grants are being applied for and received by our current device users, including a recent award for a multi-center initiative coordinated by Western Ontario Professor Grace Parraga PhD to better understand the long-term effects of COVID-19 using hyperpolarised 129Xe MRI in combination with computed tomography (CT)

Richard Hullihen, CEO of Polarean, commented: “During the period under review, Polarean achieved one of its most important milestones to date, the positive readout from our Phase III Clinical Trials. We subsequently undertook an £8.4m fundraising and welcomed our new strategic investor Bracco to our share register, alongside several new institutional investors. We are also grateful for the continued support we received from our existing long-term investors and partners. The installation of new polarisers has continued and users of our systems are publishing research at an increased rate, expanding and deepening the knowledge base of the use of hyperpolarised 129Xe in pulmonary medicine, while further validating Polarean’s technology. We look forward to providing our shareholders with updates regarding further progress and specifically the imminent submission of the Company’s NDA to the FDA.”

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

 

Enquiries:

Polarean Imaging plcwww.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive OfficerVia Walbrook PR
Jonathan Allis, Chairman 
  
SP Angel Corporate Finance LLPTel: +44 (0)20 3470 0470
David Hignell / Soltan Tagiev (Corporate Finance) 
Vadim Alexandre / Rob Rees (Corporate Broking)  
  
Walbrook PR Tel: +44 (0)20 7933 8780 or [email protected]
Paul McManus / Anna DunphyMob: +44 (0)7980 541 893 /
+44 (0)7876 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 medical 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 Group operates in an area of significant unmet medical need and the Group's technology provides a novel 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.

The Group also develops high performance MRI radiofrequency (RF) coils which are a required component for imaging 129Xe in the MRI system. The development of these coils by the Group facilitates the adoption of the Xenon technology by providing application-specific RF coils which optimise the imaging of 129Xe in MRI equipment for use as a medical diagnostic as well as a method of monitoring the efficacy of therapeutic intervention.

 

CEO Statement

Introduction
The six month period ending 30 June 2020 has seen Polarean make substantial progress towards its goal of seeking FDA approval for the Company’s drug-device combination.  After successfully completing two Phase III Clinical Trials in Q4 2019, the Company announced positive top line results of these Clinical Trials on 29 January 2020. During the first half of 2020, the Company performed the post trial in depth analysis of the results of the Clinical Trials and initiated work associated with the construction of both the drug and device components of our NDA submission.

Despite the challenging market conditions in the first half of 2020, the Company closed a financing that resulted in gross proceeds of US$10.4m (£8.4m). This financing included a new strategic investor, Bracco Imaging S.p.A., several new institutional investors and the continued support of previous VCT and EIS investors. We are encouraged with the support shown by new and existing shareholders and these additional funds will further support our preparation of our NDA for submission to the FDA, focus on preparations for commercial launch and continue development of our polariser system.

Also, during the period, former NED Jonathan Allis was appointed Chairman of Polarean after the sale of his former company, Blue Earth Diagnostics, to Bracco. We also welcomed Cyrille Petit to the Board, as a result of the Bracco investment.

Results overview
Group revenues for the first half were US$0.3m (2019: US$0.4m) and were largely derived from our collaboration with the University of Cincinnati where work under our SBIR grant has been completed.  We continue to sell our polariser systems on a research-use-only basis to academic institutions in the US, Canada and Europe. Due to COVID-19, we were unable to complete the installation of a polariser system we had delivered to KU Medical Center during December 2019. The system installation completed recently as per the Company’s announcement on 18 September 2020. Operating expenses for H1 2020 (US$3.4m) were flat compared with H1 2019 (US$3.4m), as Administrative Expenses (H1 2020 US$2.7m, H1 2019 US $3.1m) decreased after we completed the Clinical Trials and Selling and Distribution Expenses (H1 2020 US$0.4m, H1 2019 US $0.1m) increased as we began preparations for commercial launch. During H1 2020, the Company received a US$0.3m forgivable loan under the US Paycheck Protection Program (“PPP”), which was recognised as Finance Income. Our overall loss before tax decreased from US$3.4m to US$3.2m in the same comparable period, due to the PPP proceeds. The Company completed the £8.4m fundraise during H1 2020 via the issue of new equity and as at 30 June 2020 we held US US$9.2m in net cash or cash equivalents.

Post-period end events

Presentation at Medical Conferences and Studies Utilising our Technology
The Company’s technology was prominent at the American Thoracic Society and International Society of Magnetic Resonance in Medicine virtual conferences during August 2020. Over 40 abstracts related to the use of hyperpolarised 129Xe were presented at the two conferences, including the Company’s Clinical Trial results. The content of our publications and those of our customers, along with our participation is available on our website at www.polarean.com . The users of our polarisers continue to expand and document the applications of our technology across the spectrum of pulmonary disease.

The “129Xe MRI Clinical Trials Consortium” continues to discuss the application of our technology to the case of post infection COVID-19 patients to assess the long-term effects and case management of these patients.  Investigator-initiated government research grants have been submitted to study the use of our technology to assess the long-term effects of COVID-19 post infection in patients. Some of these grants have been awarded and COVID-19-related clinical research has begun.

Installation 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. We recently completed the installation of a new system at the KU Medical Center, which is starting up a research programme under the guidance of a veteran researcher in the field of hyperpolarised 129Xe imaging.

Researchers continue to apply for and receive grants to purchase our polariser systems. We are in discussions with several potential customers and anticipate additional orders during calendar year 2020. The number of systems currently installed is 23.

NDA Submission
We have continued to compile the components of the NDA submission. On 28 September 2020, the Company was granted a Small Business Waiver of Human Drug Application Fee (the “Waiver”) by the FDA. The Waiver exempts the Company from having to pay the US$2.9m filing fee for our NDA submission. We anticipate submitting our NDA to the FDA in early October 2020.

Outlook
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. There are currently 40 clinical trials ongoing into the use of 129Xe MRI according to the FDA website.

The burden of pulmonary disease in the USA is approximately US$150bn and is widespread and growing, affecting nearly 40 million Americans. Given the limitations of existing methods of diagnosis and lung disease monitoring, we estimate 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 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.

 

Richard Hullihen
Chief Executive Officer

30 September 2020

 

Consolidated unaudited statement of comprehensive income
for the six months ended 30 June 2020

  Unaudited Unaudited Audited
  6 months
ended
30.6.20
US$
 6 months
ended
30.6.19
US$
 12 months
ended
31.12.19
US$
 Note     
       
Revenue 327,896 399,639 2,301,093
Cost of sales (41,387) (75,185) (925,612)
Gross profit 286,509 324,454 1,375,481
       
Administrative expenses (2,724,411) (3,068,371) (6,010,119)
Depreciation (73,204) (4,661) (63,121)
Amortisation (359,677) (341,937) (683,873)
Selling and distribution expenses (351,754) (147,821) (324,791)
Share based payment expense (213,906)  (139,886) (305,747)
Loss from operations (3,436,443) (3,378,222) (6,012,170)
       
Finance expense (9,647) (22,356) (91,678)
Finance income 267,155 274 508
Loss on ordinary activities before taxation3(3,178,935) (3,400,304)  (6,103,340)
       
Taxation - -  -
Loss and total other comprehensive expense (3,178,935) (3,400,304)  (6,103,340)
Basic and fully diluted loss per share (US$)3(0.023) (0.034)  (0.057)

 

Consolidated unaudited statement of financial position
at 30 June 2020

  Unaudited Unaudited Audited
  As at
30.6.20
US$
 As at
30.6.19
US$
 As at
31.12.19
US$
AssetsNote     
Non-current assets      
Property, plant and equipment 312,287 13,091 355,958
Intangible assets 3,119,120 3,735,973 3,427,547
Right-of-use asset 224,414 131,773 98,263
Trade and other receivables 5,539 5,539 5,539
  3,661,360 3,886,376 3,887,307
Current assets      
Inventories 950,674  1,233,039  554,211
Trade and other receivables 522,625 1,094,988 636,783
Cash and cash equivalents 9,190,862 1,277,195 1,961,869
  10,664,161 3,605,222 3,152,863
Total assets 14,325,521 7,491,598 7,040,170
       
Equity      
Share capital477,518 49,767 55,776
Share premium 23,573,058 11,200,461 13,659,912
Group reorganisation reserve 7,813,337 7,813,337 7,813,337
Share-based payment reserve 1,584,640 1,218,221 1,370,734
Accumulated losses  (21,488,616) (15,619,993) (18,309,681)
Total equity 11,559,937 4,661,793 4,590,078
       
Liabilities      
Non-current liabilities      
Deferred income 192,817 87,029 192,817
Lease liability 5149,487 83,168 50,455
Contingent consideration 316,000 316,000 316,000
  658,304 486,197 559,272
Current liabilities      
Trade and other payables 1,985,828 1,604,792 1,773,582
Lease liability 5102,213 82,716 70,914
Deferred income 19,239 656,100 46,324
  2,107,280 2,343,608 1,890,820
Total equity and liabilities 14,325,521 7,491,598 7,040,170

 

Consolidated unaudited statement of changes in equity
at 30 June 2020

 Share
capital
Share
premium
Group
re-
organisation
Share-based
payment
reserve
Accumulated
losses
Total
equity
Balance as at 31 December 2018 (audited)49,42711,063,0757,813,3371,078,335(12,212,767)7,791,407
       
Change in accounting policy - - - - (6,922) (6,922)
Restated total equity at 1 January 201949,42711,063,0757,813,3371,078,335(12,219,689)7,784,485
       
Loss and total comprehensive income for the period----(3,400,304)(3,400,304)
Issue of shares340137,386---137,726
Share-based payments---139,886-139,886
Balance as at 30 June 2019 (unaudited)49,76711,200,4617,813,3371,218,221(15,619,993)4,661,793
Comprehensive income       
Share based payment – lapsed share options---(13,348)13,348-
Loss and total comprehensive income for the period----(2,703,036)(2,703,036)
Transaction with owners      
Issue of shares6,0092,618,903---2,624,912
Share issue costs-(159,452)---(159,452)
Share-based payments---165,861-165,861
Balance as at 31 December 2019 (audited)55,77613,659,9127,813,3371,370,734(18,309,681)4,590,078
Loss and total comprehensive income for the period----(3,178,935)(3,178,935)
Issue of shares21,74210,427,537---10,449,279
Share issue costs-(514,391)---(514,391)
Share-based payments---213,906-213,906
Balance as at 30 June 2020 (unaudited) 77,51823,573,0587,813,3371,584,640(21,488,616)11,559,937

 

Consolidated unaudited cash flow statement
for the six months ended 30 June 2020

  UnauditedUnauditedAudited
  6 months
ended
30.6.20
US$
6 months
ended
30.6.19
US$
12 months
ended
31.12.19
US$
Cash flows from operating activities    
Loss for the period before taxation (3,178,935) (3,400,304) (6,103,340)
Adjustments for non-cash/non-operating items:    
Depreciation of plant and equipment 73,2044,661 63,121
Amortisation of intangible assets 359,677341,937 683,873
Share based compensation 213,906 139,886 305,747
Interest paid -22,35691,678
Interest received (92)(274) (508)
  (2,532,240) (2,891,738)(4,959,429)
Changes in working capital:    
Increase in inventories (396,462) (581,257)(97,570)
Increase in trade and other receivables 114,157 (301,448) (14,737)
(Decrease)/increase in trade and other payables 189,40736,955 (285,074)
Increase/(decrease) in deferred revenue (27,085) 617,575 595,961
Net cash flows used from operating activities (2,652,223) (3,119,913) (4,565,709)
     
Cash flows from investing activities    
Purchase of plant and equipment (29,534)- (401,327)
Net cash used in investing activities (29,534)- (401,327)
     
Cash flows from financing activities     
Issue of shares 10,449,279 3,577,509 6,373,919
Cost of issue (514,391) (159,452)
Interest paid - (22,356) -
Interest received 92 274 508
Funds received from PPP loan 22,840--
Principal elements of lease payments (56,717)(42,793)(69,993)
Interest elements of lease payments 9,6478,873(91,678)
Net cash generated from financing activities 9,910,750 3,521,5076,053,304
     
Net increase in cash and equivalents 7,228,993404,594(1,086,268)
Cash and equivalents at beginning of period 1,961,869 875,601 875,601
Cash and equivalents at end of period 9,190,8621,277,1951,961,869

2019

Half-year Report

30 September 2020

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary investigational drug-device combination diagnostic for magnetic resonance imaging (“MRI”), announces its unaudited interim results for the six months ended 30 June 2020.

CEO Statement
Statement of Comprehensive Income
Statement of Financial Position
Statement of Changes in Equity
Cash Flow Statement
Download

To view a full version of the results in 
PDF format click here

Highlights

  • Positive results from Phase III trials (the “Clinical Trials”) announced in January 2020
  • Raised gross proceeds of £8.4m in April 2020, which included a £2.2m subscription from new strategic investor Bracco Imaging S.p.A. (“Bracco”)
  • Appointment of former NED Jonathan Allis as Chairman in February 2020
  • Appointment of Cyrille Petit as Non-Executive Director and representative of Bracco in June 2020
  • Net cash of US$9.2m as of 30 June 2020

Post-period end

  • Significant progress toward submission of New Drug Application (“NDA”)
    • the United States Food and Drug Administration (“FDA”) on 28 September 2020
    • NDA to be submitted in early October 2020
  • Presentation of data at the American Thoracic Society and the International Society for Magnetic Resonance in Medicine virtual conferences
  • Installed a 9820 Xenon Polariser system at University of Kansas Medical Center (“KU Medical Center”)
  • Government COVID-19-related grants are being applied for and received by our current device users, including a recent award for a multi-center initiative coordinated by Western Ontario Professor Grace Parraga PhD to better understand the long-term effects of COVID-19 using hyperpolarised 129Xe MRI in combination with computed tomography (CT)

Richard Hullihen, CEO of Polarean, commented: “During the period under review, Polarean achieved one of its most important milestones to date, the positive readout from our Phase III Clinical Trials. We subsequently undertook an £8.4m fundraising and welcomed our new strategic investor Bracco to our share register, alongside several new institutional investors. We are also grateful for the continued support we received from our existing long-term investors and partners. The installation of new polarisers has continued and users of our systems are publishing research at an increased rate, expanding and deepening the knowledge base of the use of hyperpolarised 129Xe in pulmonary medicine, while further validating Polarean’s technology. We look forward to providing our shareholders with updates regarding further progress and specifically the imminent submission of the Company’s NDA to the FDA.”

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

 

Enquiries:

Polarean Imaging plcwww.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive OfficerVia Walbrook PR
Jonathan Allis, Chairman 
  
SP Angel Corporate Finance LLPTel: +44 (0)20 3470 0470
David Hignell / Soltan Tagiev (Corporate Finance) 
Vadim Alexandre / Rob Rees (Corporate Broking)  
  
Walbrook PR Tel: +44 (0)20 7933 8780 or [email protected]
Paul McManus / Anna DunphyMob: +44 (0)7980 541 893 /
+44 (0)7876 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 medical 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 Group operates in an area of significant unmet medical need and the Group's technology provides a novel 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.

The Group also develops high performance MRI radiofrequency (RF) coils which are a required component for imaging 129Xe in the MRI system. The development of these coils by the Group facilitates the adoption of the Xenon technology by providing application-specific RF coils which optimise the imaging of 129Xe in MRI equipment for use as a medical diagnostic as well as a method of monitoring the efficacy of therapeutic intervention.

 

CEO Statement

Introduction
The six month period ending 30 June 2020 has seen Polarean make substantial progress towards its goal of seeking FDA approval for the Company’s drug-device combination.  After successfully completing two Phase III Clinical Trials in Q4 2019, the Company announced positive top line results of these Clinical Trials on 29 January 2020. During the first half of 2020, the Company performed the post trial in depth analysis of the results of the Clinical Trials and initiated work associated with the construction of both the drug and device components of our NDA submission.

Despite the challenging market conditions in the first half of 2020, the Company closed a financing that resulted in gross proceeds of US$10.4m (£8.4m). This financing included a new strategic investor, Bracco Imaging S.p.A., several new institutional investors and the continued support of previous VCT and EIS investors. We are encouraged with the support shown by new and existing shareholders and these additional funds will further support our preparation of our NDA for submission to the FDA, focus on preparations for commercial launch and continue development of our polariser system.

Also, during the period, former NED Jonathan Allis was appointed Chairman of Polarean after the sale of his former company, Blue Earth Diagnostics, to Bracco. We also welcomed Cyrille Petit to the Board, as a result of the Bracco investment.

Results overview
Group revenues for the first half were US$0.3m (2019: US$0.4m) and were largely derived from our collaboration with the University of Cincinnati where work under our SBIR grant has been completed.  We continue to sell our polariser systems on a research-use-only basis to academic institutions in the US, Canada and Europe. Due to COVID-19, we were unable to complete the installation of a polariser system we had delivered to KU Medical Center during December 2019. The system installation completed recently as per the Company’s announcement on 18 September 2020. Operating expenses for H1 2020 (US$3.4m) were flat compared with H1 2019 (US$3.4m), as Administrative Expenses (H1 2020 US$2.7m, H1 2019 US $3.1m) decreased after we completed the Clinical Trials and Selling and Distribution Expenses (H1 2020 US$0.4m, H1 2019 US $0.1m) increased as we began preparations for commercial launch. During H1 2020, the Company received a US$0.3m forgivable loan under the US Paycheck Protection Program (“PPP”), which was recognised as Finance Income. Our overall loss before tax decreased from US$3.4m to US$3.2m in the same comparable period, due to the PPP proceeds. The Company completed the £8.4m fundraise during H1 2020 via the issue of new equity and as at 30 June 2020 we held US US$9.2m in net cash or cash equivalents.

Post-period end events

Presentation at Medical Conferences and Studies Utilising our Technology
The Company’s technology was prominent at the American Thoracic Society and International Society of Magnetic Resonance in Medicine virtual conferences during August 2020. Over 40 abstracts related to the use of hyperpolarised 129Xe were presented at the two conferences, including the Company’s Clinical Trial results. The content of our publications and those of our customers, along with our participation is available on our website at www.polarean.com . The users of our polarisers continue to expand and document the applications of our technology across the spectrum of pulmonary disease.

The “129Xe MRI Clinical Trials Consortium” continues to discuss the application of our technology to the case of post infection COVID-19 patients to assess the long-term effects and case management of these patients.  Investigator-initiated government research grants have been submitted to study the use of our technology to assess the long-term effects of COVID-19 post infection in patients. Some of these grants have been awarded and COVID-19-related clinical research has begun.

Installation 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. We recently completed the installation of a new system at the KU Medical Center, which is starting up a research programme under the guidance of a veteran researcher in the field of hyperpolarised 129Xe imaging.

Researchers continue to apply for and receive grants to purchase our polariser systems. We are in discussions with several potential customers and anticipate additional orders during calendar year 2020. The number of systems currently installed is 23.

NDA Submission
We have continued to compile the components of the NDA submission. On 28 September 2020, the Company was granted a Small Business Waiver of Human Drug Application Fee (the “Waiver”) by the FDA. The Waiver exempts the Company from having to pay the US$2.9m filing fee for our NDA submission. We anticipate submitting our NDA to the FDA in early October 2020.

Outlook
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. There are currently 40 clinical trials ongoing into the use of 129Xe MRI according to the FDA website.

The burden of pulmonary disease in the USA is approximately US$150bn and is widespread and growing, affecting nearly 40 million Americans. Given the limitations of existing methods of diagnosis and lung disease monitoring, we estimate 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 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.

 

Richard Hullihen
Chief Executive Officer

30 September 2020

 

Consolidated unaudited statement of comprehensive income
for the six months ended 30 June 2020

  Unaudited Unaudited Audited
  6 months
ended
30.6.20
US$
 6 months
ended
30.6.19
US$
 12 months
ended
31.12.19
US$
 Note     
       
Revenue 327,896 399,639 2,301,093
Cost of sales (41,387) (75,185) (925,612)
Gross profit 286,509 324,454 1,375,481
       
Administrative expenses (2,724,411) (3,068,371) (6,010,119)
Depreciation (73,204) (4,661) (63,121)
Amortisation (359,677) (341,937) (683,873)
Selling and distribution expenses (351,754) (147,821) (324,791)
Share based payment expense (213,906)  (139,886) (305,747)
Loss from operations (3,436,443) (3,378,222) (6,012,170)
       
Finance expense (9,647) (22,356) (91,678)
Finance income 267,155 274 508
Loss on ordinary activities before taxation3(3,178,935) (3,400,304)  (6,103,340)
       
Taxation - -  -
Loss and total other comprehensive expense (3,178,935) (3,400,304)  (6,103,340)
Basic and fully diluted loss per share (US$)3(0.023) (0.034)  (0.057)

 

Consolidated unaudited statement of financial position
at 30 June 2020

  Unaudited Unaudited Audited
  As at
30.6.20
US$
 As at
30.6.19
US$
 As at
31.12.19
US$
AssetsNote     
Non-current assets      
Property, plant and equipment 312,287 13,091 355,958
Intangible assets 3,119,120 3,735,973 3,427,547
Right-of-use asset 224,414 131,773 98,263
Trade and other receivables 5,539 5,539 5,539
  3,661,360 3,886,376 3,887,307
Current assets      
Inventories 950,674  1,233,039  554,211
Trade and other receivables 522,625 1,094,988 636,783
Cash and cash equivalents 9,190,862 1,277,195 1,961,869
  10,664,161 3,605,222 3,152,863
Total assets 14,325,521 7,491,598 7,040,170
       
Equity      
Share capital477,518 49,767 55,776
Share premium 23,573,058 11,200,461 13,659,912
Group reorganisation reserve 7,813,337 7,813,337 7,813,337
Share-based payment reserve 1,584,640 1,218,221 1,370,734
Accumulated losses  (21,488,616) (15,619,993) (18,309,681)
Total equity 11,559,937 4,661,793 4,590,078
       
Liabilities      
Non-current liabilities      
Deferred income 192,817 87,029 192,817
Lease liability 5149,487 83,168 50,455
Contingent consideration 316,000 316,000 316,000
  658,304 486,197 559,272
Current liabilities      
Trade and other payables 1,985,828 1,604,792 1,773,582
Lease liability 5102,213 82,716 70,914
Deferred income 19,239 656,100 46,324
  2,107,280 2,343,608 1,890,820
Total equity and liabilities 14,325,521 7,491,598 7,040,170

 

Consolidated unaudited statement of changes in equity
at 30 June 2020

 Share
capital
Share
premium
Group
re-
organisation
Share-based
payment
reserve
Accumulated
losses
Total
equity
Balance as at 31 December 2018 (audited)49,42711,063,0757,813,3371,078,335(12,212,767)7,791,407
       
Change in accounting policy - - - - (6,922) (6,922)
Restated total equity at 1 January 201949,42711,063,0757,813,3371,078,335(12,219,689)7,784,485
       
Loss and total comprehensive income for the period----(3,400,304)(3,400,304)
Issue of shares340137,386---137,726
Share-based payments---139,886-139,886
Balance as at 30 June 2019 (unaudited)49,76711,200,4617,813,3371,218,221(15,619,993)4,661,793
Comprehensive income       
Share based payment – lapsed share options---(13,348)13,348-
Loss and total comprehensive income for the period----(2,703,036)(2,703,036)
Transaction with owners      
Issue of shares6,0092,618,903---2,624,912
Share issue costs-(159,452)---(159,452)
Share-based payments---165,861-165,861
Balance as at 31 December 2019 (audited)55,77613,659,9127,813,3371,370,734(18,309,681)4,590,078
Loss and total comprehensive income for the period----(3,178,935)(3,178,935)
Issue of shares21,74210,427,537---10,449,279
Share issue costs-(514,391)---(514,391)
Share-based payments---213,906-213,906
Balance as at 30 June 2020 (unaudited) 77,51823,573,0587,813,3371,584,640(21,488,616)11,559,937

 

Consolidated unaudited cash flow statement
for the six months ended 30 June 2020

  UnauditedUnauditedAudited
  6 months
ended
30.6.20
US$
6 months
ended
30.6.19
US$
12 months
ended
31.12.19
US$
Cash flows from operating activities    
Loss for the period before taxation (3,178,935) (3,400,304) (6,103,340)
Adjustments for non-cash/non-operating items:    
Depreciation of plant and equipment 73,2044,661 63,121
Amortisation of intangible assets 359,677341,937 683,873
Share based compensation 213,906 139,886 305,747
Interest paid -22,35691,678
Interest received (92)(274) (508)
  (2,532,240) (2,891,738)(4,959,429)
Changes in working capital:    
Increase in inventories (396,462) (581,257)(97,570)
Increase in trade and other receivables 114,157 (301,448) (14,737)
(Decrease)/increase in trade and other payables 189,40736,955 (285,074)
Increase/(decrease) in deferred revenue (27,085) 617,575 595,961
Net cash flows used from operating activities (2,652,223) (3,119,913) (4,565,709)
     
Cash flows from investing activities    
Purchase of plant and equipment (29,534)- (401,327)
Net cash used in investing activities (29,534)- (401,327)
     
Cash flows from financing activities     
Issue of shares 10,449,279 3,577,509 6,373,919
Cost of issue (514,391) (159,452)
Interest paid - (22,356) -
Interest received 92 274 508
Funds received from PPP loan 22,840--
Principal elements of lease payments (56,717)(42,793)(69,993)
Interest elements of lease payments 9,6478,873(91,678)
Net cash generated from financing activities 9,910,750 3,521,5076,053,304
     
Net increase in cash and equivalents 7,228,993404,594(1,086,268)
Cash and equivalents at beginning of period 1,961,869 875,601 875,601
Cash and equivalents at end of period 9,190,8621,277,1951,961,869

2018

Half-year Report

30 September 2020

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary investigational drug-device combination diagnostic for magnetic resonance imaging (“MRI”), announces its unaudited interim results for the six months ended 30 June 2020.

CEO Statement
Statement of Comprehensive Income
Statement of Financial Position
Statement of Changes in Equity
Cash Flow Statement
Download

To view a full version of the results in 
PDF format click here

Highlights

  • Positive results from Phase III trials (the “Clinical Trials”) announced in January 2020
  • Raised gross proceeds of £8.4m in April 2020, which included a £2.2m subscription from new strategic investor Bracco Imaging S.p.A. (“Bracco”)
  • Appointment of former NED Jonathan Allis as Chairman in February 2020
  • Appointment of Cyrille Petit as Non-Executive Director and representative of Bracco in June 2020
  • Net cash of US$9.2m as of 30 June 2020

Post-period end

  • Significant progress toward submission of New Drug Application (“NDA”)
    • the United States Food and Drug Administration (“FDA”) on 28 September 2020
    • NDA to be submitted in early October 2020
  • Presentation of data at the American Thoracic Society and the International Society for Magnetic Resonance in Medicine virtual conferences
  • Installed a 9820 Xenon Polariser system at University of Kansas Medical Center (“KU Medical Center”)
  • Government COVID-19-related grants are being applied for and received by our current device users, including a recent award for a multi-center initiative coordinated by Western Ontario Professor Grace Parraga PhD to better understand the long-term effects of COVID-19 using hyperpolarised 129Xe MRI in combination with computed tomography (CT)

Richard Hullihen, CEO of Polarean, commented: “During the period under review, Polarean achieved one of its most important milestones to date, the positive readout from our Phase III Clinical Trials. We subsequently undertook an £8.4m fundraising and welcomed our new strategic investor Bracco to our share register, alongside several new institutional investors. We are also grateful for the continued support we received from our existing long-term investors and partners. The installation of new polarisers has continued and users of our systems are publishing research at an increased rate, expanding and deepening the knowledge base of the use of hyperpolarised 129Xe in pulmonary medicine, while further validating Polarean’s technology. We look forward to providing our shareholders with updates regarding further progress and specifically the imminent submission of the Company’s NDA to the FDA.”

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

 

Enquiries:

Polarean Imaging plcwww.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive OfficerVia Walbrook PR
Jonathan Allis, Chairman 
  
SP Angel Corporate Finance LLPTel: +44 (0)20 3470 0470
David Hignell / Soltan Tagiev (Corporate Finance) 
Vadim Alexandre / Rob Rees (Corporate Broking)  
  
Walbrook PR Tel: +44 (0)20 7933 8780 or [email protected]
Paul McManus / Anna DunphyMob: +44 (0)7980 541 893 /
+44 (0)7876 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 medical 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 Group operates in an area of significant unmet medical need and the Group's technology provides a novel 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.

The Group also develops high performance MRI radiofrequency (RF) coils which are a required component for imaging 129Xe in the MRI system. The development of these coils by the Group facilitates the adoption of the Xenon technology by providing application-specific RF coils which optimise the imaging of 129Xe in MRI equipment for use as a medical diagnostic as well as a method of monitoring the efficacy of therapeutic intervention.

 

CEO Statement

Introduction
The six month period ending 30 June 2020 has seen Polarean make substantial progress towards its goal of seeking FDA approval for the Company’s drug-device combination.  After successfully completing two Phase III Clinical Trials in Q4 2019, the Company announced positive top line results of these Clinical Trials on 29 January 2020. During the first half of 2020, the Company performed the post trial in depth analysis of the results of the Clinical Trials and initiated work associated with the construction of both the drug and device components of our NDA submission.

Despite the challenging market conditions in the first half of 2020, the Company closed a financing that resulted in gross proceeds of US$10.4m (£8.4m). This financing included a new strategic investor, Bracco Imaging S.p.A., several new institutional investors and the continued support of previous VCT and EIS investors. We are encouraged with the support shown by new and existing shareholders and these additional funds will further support our preparation of our NDA for submission to the FDA, focus on preparations for commercial launch and continue development of our polariser system.

Also, during the period, former NED Jonathan Allis was appointed Chairman of Polarean after the sale of his former company, Blue Earth Diagnostics, to Bracco. We also welcomed Cyrille Petit to the Board, as a result of the Bracco investment.

Results overview
Group revenues for the first half were US$0.3m (2019: US$0.4m) and were largely derived from our collaboration with the University of Cincinnati where work under our SBIR grant has been completed.  We continue to sell our polariser systems on a research-use-only basis to academic institutions in the US, Canada and Europe. Due to COVID-19, we were unable to complete the installation of a polariser system we had delivered to KU Medical Center during December 2019. The system installation completed recently as per the Company’s announcement on 18 September 2020. Operating expenses for H1 2020 (US$3.4m) were flat compared with H1 2019 (US$3.4m), as Administrative Expenses (H1 2020 US$2.7m, H1 2019 US $3.1m) decreased after we completed the Clinical Trials and Selling and Distribution Expenses (H1 2020 US$0.4m, H1 2019 US $0.1m) increased as we began preparations for commercial launch. During H1 2020, the Company received a US$0.3m forgivable loan under the US Paycheck Protection Program (“PPP”), which was recognised as Finance Income. Our overall loss before tax decreased from US$3.4m to US$3.2m in the same comparable period, due to the PPP proceeds. The Company completed the £8.4m fundraise during H1 2020 via the issue of new equity and as at 30 June 2020 we held US US$9.2m in net cash or cash equivalents.

Post-period end events

Presentation at Medical Conferences and Studies Utilising our Technology
The Company’s technology was prominent at the American Thoracic Society and International Society of Magnetic Resonance in Medicine virtual conferences during August 2020. Over 40 abstracts related to the use of hyperpolarised 129Xe were presented at the two conferences, including the Company’s Clinical Trial results. The content of our publications and those of our customers, along with our participation is available on our website at www.polarean.com . The users of our polarisers continue to expand and document the applications of our technology across the spectrum of pulmonary disease.

The “129Xe MRI Clinical Trials Consortium” continues to discuss the application of our technology to the case of post infection COVID-19 patients to assess the long-term effects and case management of these patients.  Investigator-initiated government research grants have been submitted to study the use of our technology to assess the long-term effects of COVID-19 post infection in patients. Some of these grants have been awarded and COVID-19-related clinical research has begun.

Installation 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. We recently completed the installation of a new system at the KU Medical Center, which is starting up a research programme under the guidance of a veteran researcher in the field of hyperpolarised 129Xe imaging.

Researchers continue to apply for and receive grants to purchase our polariser systems. We are in discussions with several potential customers and anticipate additional orders during calendar year 2020. The number of systems currently installed is 23.

NDA Submission
We have continued to compile the components of the NDA submission. On 28 September 2020, the Company was granted a Small Business Waiver of Human Drug Application Fee (the “Waiver”) by the FDA. The Waiver exempts the Company from having to pay the US$2.9m filing fee for our NDA submission. We anticipate submitting our NDA to the FDA in early October 2020.

Outlook
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. There are currently 40 clinical trials ongoing into the use of 129Xe MRI according to the FDA website.

The burden of pulmonary disease in the USA is approximately US$150bn and is widespread and growing, affecting nearly 40 million Americans. Given the limitations of existing methods of diagnosis and lung disease monitoring, we estimate 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 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.

 

Richard Hullihen
Chief Executive Officer

30 September 2020

 

Consolidated unaudited statement of comprehensive income
for the six months ended 30 June 2020

  Unaudited Unaudited Audited
  6 months
ended
30.6.20
US$
 6 months
ended
30.6.19
US$
 12 months
ended
31.12.19
US$
 Note     
       
Revenue 327,896 399,639 2,301,093
Cost of sales (41,387) (75,185) (925,612)
Gross profit 286,509 324,454 1,375,481
       
Administrative expenses (2,724,411) (3,068,371) (6,010,119)
Depreciation (73,204) (4,661) (63,121)
Amortisation (359,677) (341,937) (683,873)
Selling and distribution expenses (351,754) (147,821) (324,791)
Share based payment expense (213,906)  (139,886) (305,747)
Loss from operations (3,436,443) (3,378,222) (6,012,170)
       
Finance expense (9,647) (22,356) (91,678)
Finance income 267,155 274 508
Loss on ordinary activities before taxation3(3,178,935) (3,400,304)  (6,103,340)
       
Taxation - -  -
Loss and total other comprehensive expense (3,178,935) (3,400,304)  (6,103,340)
Basic and fully diluted loss per share (US$)3(0.023) (0.034)  (0.057)

 

Consolidated unaudited statement of financial position
at 30 June 2020

  Unaudited Unaudited Audited
  As at
30.6.20
US$
 As at
30.6.19
US$
 As at
31.12.19
US$
AssetsNote     
Non-current assets      
Property, plant and equipment 312,287 13,091 355,958
Intangible assets 3,119,120 3,735,973 3,427,547
Right-of-use asset 224,414 131,773 98,263
Trade and other receivables 5,539 5,539 5,539
  3,661,360 3,886,376 3,887,307
Current assets      
Inventories 950,674  1,233,039  554,211
Trade and other receivables 522,625 1,094,988 636,783
Cash and cash equivalents 9,190,862 1,277,195 1,961,869
  10,664,161 3,605,222 3,152,863
Total assets 14,325,521 7,491,598 7,040,170
       
Equity      
Share capital477,518 49,767 55,776
Share premium 23,573,058 11,200,461 13,659,912
Group reorganisation reserve 7,813,337 7,813,337 7,813,337
Share-based payment reserve 1,584,640 1,218,221 1,370,734
Accumulated losses  (21,488,616) (15,619,993) (18,309,681)
Total equity 11,559,937 4,661,793 4,590,078
       
Liabilities      
Non-current liabilities      
Deferred income 192,817 87,029 192,817
Lease liability 5149,487 83,168 50,455
Contingent consideration 316,000 316,000 316,000
  658,304 486,197 559,272
Current liabilities      
Trade and other payables 1,985,828 1,604,792 1,773,582
Lease liability 5102,213 82,716 70,914
Deferred income 19,239 656,100 46,324
  2,107,280 2,343,608 1,890,820
Total equity and liabilities 14,325,521 7,491,598 7,040,170

 

Consolidated unaudited statement of changes in equity
at 30 June 2020

 Share
capital
Share
premium
Group
re-
organisation
Share-based
payment
reserve
Accumulated
losses
Total
equity
Balance as at 31 December 2018 (audited)49,42711,063,0757,813,3371,078,335(12,212,767)7,791,407
       
Change in accounting policy - - - - (6,922) (6,922)
Restated total equity at 1 January 201949,42711,063,0757,813,3371,078,335(12,219,689)7,784,485
       
Loss and total comprehensive income for the period----(3,400,304)(3,400,304)
Issue of shares340137,386---137,726
Share-based payments---139,886-139,886
Balance as at 30 June 2019 (unaudited)49,76711,200,4617,813,3371,218,221(15,619,993)4,661,793
Comprehensive income       
Share based payment – lapsed share options---(13,348)13,348-
Loss and total comprehensive income for the period----(2,703,036)(2,703,036)
Transaction with owners      
Issue of shares6,0092,618,903---2,624,912
Share issue costs-(159,452)---(159,452)
Share-based payments---165,861-165,861
Balance as at 31 December 2019 (audited)55,77613,659,9127,813,3371,370,734(18,309,681)4,590,078
Loss and total comprehensive income for the period----(3,178,935)(3,178,935)
Issue of shares21,74210,427,537---10,449,279
Share issue costs-(514,391)---(514,391)
Share-based payments---213,906-213,906
Balance as at 30 June 2020 (unaudited) 77,51823,573,0587,813,3371,584,640(21,488,616)11,559,937

 

Consolidated unaudited cash flow statement
for the six months ended 30 June 2020

  UnauditedUnauditedAudited
  6 months
ended
30.6.20
US$
6 months
ended
30.6.19
US$
12 months
ended
31.12.19
US$
Cash flows from operating activities    
Loss for the period before taxation (3,178,935) (3,400,304) (6,103,340)
Adjustments for non-cash/non-operating items:    
Depreciation of plant and equipment 73,2044,661 63,121
Amortisation of intangible assets 359,677341,937 683,873
Share based compensation 213,906 139,886 305,747
Interest paid -22,35691,678
Interest received (92)(274) (508)
  (2,532,240) (2,891,738)(4,959,429)
Changes in working capital:    
Increase in inventories (396,462) (581,257)(97,570)
Increase in trade and other receivables 114,157 (301,448) (14,737)
(Decrease)/increase in trade and other payables 189,40736,955 (285,074)
Increase/(decrease) in deferred revenue (27,085) 617,575 595,961
Net cash flows used from operating activities (2,652,223) (3,119,913) (4,565,709)
     
Cash flows from investing activities    
Purchase of plant and equipment (29,534)- (401,327)
Net cash used in investing activities (29,534)- (401,327)
     
Cash flows from financing activities     
Issue of shares 10,449,279 3,577,509 6,373,919
Cost of issue (514,391) (159,452)
Interest paid - (22,356) -
Interest received 92 274 508
Funds received from PPP loan 22,840--
Principal elements of lease payments (56,717)(42,793)(69,993)
Interest elements of lease payments 9,6478,873(91,678)
Net cash generated from financing activities 9,910,750 3,521,5076,053,304
     
Net increase in cash and equivalents 7,228,993404,594(1,086,268)
Cash and equivalents at beginning of period 1,961,869 875,601 875,601
Cash and equivalents at end of period 9,190,8621,277,1951,961,869

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