Corporate News

Notice of Annual General Meeting

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:

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.

back to top

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

back to top

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

back to top

Consolidated Statement of Comprehensive Income

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.

back to top

Consolidated Statement of Financial Position

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 

back to top

Company Statement of Financial Position

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

back to top

Consolidated Statement of Changes in Equity

Company Statement of Changes in Equity

back to top

Consolidated Statement of Cash Flows

Company Statement of Cash Flows

back to top

Notes on Financial Statements

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

Notice of Annual General Meeting

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:

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.

back to top

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

back to top

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

back to top

Consolidated Statement of Comprehensive Income

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.

back to top

Consolidated Statement of Financial Position

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 

back to top

Company Statement of Financial Position

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

back to top

Consolidated Statement of Changes in Equity

Company Statement of Changes in Equity

back to top

Consolidated Statement of Cash Flows

Company Statement of Cash Flows

back to top

Notes on Financial Statements

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

Notice of Annual General Meeting

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:

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.

back to top

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

back to top

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

back to top

Consolidated Statement of Comprehensive Income

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.

back to top

Consolidated Statement of Financial Position

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 

back to top

Company Statement of Financial Position

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

back to top

Consolidated Statement of Changes in Equity

Company Statement of Changes in Equity

back to top

Consolidated Statement of Cash Flows

Company Statement of Cash Flows

back to top

Notes on Financial Statements

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

2020

Notice of Annual General Meeting

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:

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.

back to top

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

back to top

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

back to top

Consolidated Statement of Comprehensive Income

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.

back to top

Consolidated Statement of Financial Position

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 

back to top

Company Statement of Financial Position

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

back to top

Consolidated Statement of Changes in Equity

Company Statement of Changes in Equity

back to top

Consolidated Statement of Cash Flows

Company Statement of Cash Flows

back to top

Notes on Financial Statements

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

Notice of Annual General Meeting

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:

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.

back to top

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

back to top

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

back to top

Consolidated Statement of Comprehensive Income

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.

back to top

Consolidated Statement of Financial Position

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 

back to top

Company Statement of Financial Position