Half-year Report

Polarean Imaging PLC
07 September 2023
 

Polarean Imaging Plc

("Polarean" or the "Company")

 

Half-year Report 

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging ("MRI") of the lungs, announces its unaudited interim results for the six months ended 30 June 2023.

 

Highlights

·    Secured the first order for a xenon gas blend cylinder for the production of XENOVIEW™ (xenon Xe 129 hyperpolarised) from Cincinnati Children's Hospital Medical Center leading to the first clinical scan in North America, representing a key milestone in the execution of the commercial plan

·    Entered into a collaboration agreement with multinational medical imaging technology company Philips to advance the field of hyperpolarised Xenon MRI

·    Submitted a post-marketing commitment plan to the US Food and Drug Administration ("FDA") to seek approval prior to 30 June 2024 to expand the minimum current age of XENOVIEW MRI in children from twelve to six years

·    Granted New Chemical Entity designation for XENOVIEW by the FDA, with a five-year market exclusivity period

·    Selected as one of the featured companies at the American Thoracic Society's 2023 Respiratory Innovation Summit

·    Appointed Christopher von Jako, Ph.D. as new Chief Executive Officer and Board Director

·    Net cash of US$9.9m as of 30 June 2023, which based on strategic decisions, is now expected to fund the Company until the end of Q2 2024

 

Post-period end

·    Upgraded the University of Missouri Health Care polariser system to a clinical configuration accompanied by the sale of an initial xenon gas blend cylinder for the production of XENOVIEW

·    Received 510(k) clearance from the FDA for the Company's specialised MRI chest coil to now include Philips 3.0T MRI scanners for the visualisation of Xenon 129 nuclei

·    New reimbursement C-code (C9791) from the US Centers for Medicare & Medicaid Services ("CMS") for the XENOVIEW MRI technology which corresponds to a payment range of between US$1,201 to US$1,300

·    Requested and granted a formal Type B meeting in October 2023 with the FDA's Center for Drug Evaluation and Research division to seek guidance on the clinical plan related to the XENOVIEW indication expansion, which includes both regional visualisation and quantitative assessment of gas exchange and microvascular haemodynamics for both pulmonary and cardio-pulmonary diseases

 

Christopher von Jako, Ph.D., CEO of Polarean, commented: "Today marks 80 days since I joined the dynamic Polarean team, and I am very excited about our life-altering imaging platform technology and how we can help individuals suffering from lung disease. Over the past two months, we began revisiting all our strategic business initiatives with the intent of creating increased focus on key business drivers. As a result, we have identified five specific growth initiatives, which include driving utilisation at our newly established clinical sites, expanding to our highest priority targeted clinical sites, developing key industry partnerships, establishing reimbursement coverage and payment, and expanding our current FDA indication to include the even higher value interstitial lung and pulmonary vascular diseases.

 

"I am also delighted that we received a final determination from CMS that our new C-code is linked to a new technology APC 1551, which corresponds to a payment range of between US$1,201 to US$1,300. This reimbursement code should be helpful as we market XENOVIEW for the evaluation of ventilation, which is highly useful in obstructive lung diseases like asthma, COPD, and cystic fibrosis.

 

"Our new focus will also result in reduced operating expenses going forward which allows us to extend our cash runway until the end of Q2 2024.  All our initiatives are guided by our belief and desire to revolutionise pulmonary and cardio-pulmonary medicine."  

 

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.

 

Enquiries:

 

Polarean Imaging plc

www.polarean.com / www.polarean-ir.com

Christopher von Jako, Ph.D, Chief Executive Officer

Via Walbrook PR

Charles Osborne, Chief Financial Officer

 


 

Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)

+44 (0)20 7710 7600

Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment Banking)


Nick Adams / Nick Harland (Corporate Broking)




Walbrook PR

Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com

Anna Dunphy / Phillip Marriage

Mob: +44 (0)7876 741 001 / +44 (0)7867 984 082

 

About Polarean (www.polarean.com)

 

The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space. Polarean aspires to revolutionise pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community in need of new solutions to evaluate lung ventilation, diagnose disease, characterise disease progression, and monitor response to treatment. By researching, developing, and commercialising novel imaging solutions with a non-invasive and radiation-free functional imaging platform. Polarean's vision is to help address the global unmet medical needs of more than 500 million patients worldwide suffering with chronic respiratory disease. Polarean is a leader in the field of hyperpolarisation science and has successfully developed the first and only hyperpolarised MRI contrast agent to be approved in the United States.   The Company also commercialises systems (such as the HPX hyperpolarisation system), accessories (such as Xe-specific chest coils and phantoms), and FDA-cleared post-processing software (to support ventilation defect analysis), to support fully integrated modern respiratory imaging operations.

 

XENOVIEW IMPORTANT SAFETY INFORMATION

 

Indication

XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

 

Limitations of Use

XENOVIEW has not been evaluated for use with lung perfusion imaging.

 

CONTRAINDICATIONS

None.

 

Warnings and Precautions

Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold.

 

Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated.

 

 

 

Adverse Reactions

Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness.  Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.

 

Please see full prescribing information at www.xenoview.net

 

 

 


                                                                                 


CEO Statement

 

Introduction

 

I am excited to have recently joined Polarean, and was initially attracted to the Company's promising functional imaging technology, the large clinical unmet need that it addresses, and the business model. I am confident that our technology will be clinically useful for the pulmonary diseases covered by the current FDA approval in ventilation, including asthma, COPD, and cystic fibrosis. In addition, it has even greater potential as we expand into the high-value areas of interstitial lung and pulmonary vascular disease. The XENOVIEW MRI technology has the potential to transform the visualisation and measurement of pulmonary and cardio-pulmonary disease.

 

I have spent the last two months working with the team to understand the technology and the commercial opportunities. I am very encouraged by the scientific and medical community's appreciation for the large unmet medical need in the pulmonary functional imaging space, and we are in the process of refining our commercialisation strategy to deploy XENOVIEW. My long tenure in the medical device industry, particularly focused on large capital products, will be very valuable as we look to ramp up commercial sales.

  

Results overview 

 

Polarean received FDA approval in December 2022, which enabled the Company to start selling its products to the clinical market.  As per US regulations, we could not start to market the system and services until we received FDA approval. Our efforts during the first half of 2023 were mainly focused on preparing our legacy research sites for the conversion to clinical scanning, obtaining the required state drug licenses, and beginning the commercial launch process. Whilst we have been encouraged by the successful clinical conversion of two of our prominent research sites, and the highly positive response from physicians in both existing and prospective new sites, the process has gone more slowly than the Company had originally hoped. The slower-than-expected early commercial sales are primarily due to the hospital contracting process, which we continue to actively address. From my perspective, the early results from this type of first-in-class medical imaging technology launch are not different than in my past experiences.

 

Group revenues for the first half were US$0.1m (H1 2022: US$0.8m), based on sales of xenon gas blend cylinders and parts and service for polarisers installed at our customer locations.  Operating expenses for H1 2023 (US$7.7m) increased from H1 2022 (US$7.0m), as we incurred commercialisation costs to launch our products. In H1 2023, the Company recognised finance income of US$0.2m (H1 2022: US$nil), due to interest earned on our bank deposits.  Other gains / (losses) of US$0.1m (H1 2022: US$(0.2m)) were due to the strengthening of the British pound during the 2023 period versus a weakening of the British pound during the 2022 period. The overall loss before tax increased to US$7.4m in H1 2023 (H1 2022: US$6.9m), due to higher operating expenses, partially offset by the interest income and foreign exchange gain described above.  As of 30 June 2022, the Company held US$9.9m in net cash or cash equivalents.

 

Commercialisation plans

 

 

Outlook

1)    Driving utilisation at our newly established clinical sites;

2)    Expanding to our highest-priority targeted clinical sites;

3)    Establishing reimbursement coverage and payment;

4)    Developing key industry partnerships; and

5)    Planning for the expansion of our current FDA labeling to include visualisation and measurement of gas exchange

 

 

Christopher von Jako, Ph.D.

Chief Executive Officer

 

7 September 2023

 

 

 

 

POLAREAN IMAGING PLC

Consolidated unaudited statement of comprehensive income

for the six months ended 30 June 2023

 

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

 

 

6 months ended

30 June 2023

US$

 

6 months ended

30 June 2022

US$

 

12 months ended

31 December 2022

US$

 

Note






 

 






Revenue

 

142,384


834,087


1,033,008

Cost of sales


(60,484)


(539,247)


(684,732)

Gross profit

 

81,900

 

294,840

 

348,276


 






Administrative expenses

 

(1,865,084)


(1,480,119)


(2,839,544)

Research, development and regulatory expenses

 

(2,460,547)


(2,522,166)


(5,625,222)

Depreciation

 

(165,509)


(139,058)


(277,461)

Amortisation

 

(306,126)


(392,739)


(760,780)

Selling and distribution expenses


(2,453,477)


(1,738,265)


(3,310,592)

Share based payment expense


(433,892)


(701,832)


(1,205.247)

Total operating expenses


(7,684,635)93,580)


(6,974,179)984,594)


(14,018,846)

Loss from operations


(7,602,735)0)

 

(6,679,339)

 

(13,670,570)








Finance income


192,826


2,530


35,045

Finance expense


(8,945)


(12,944)

 


(23,762)

Other gains/(losses)-net


67,685


(228,378)


(246,309)

Loss on ordinary activities before taxation

3

(7,351,169)

 

(6,918,131)

 

(13,905,596)


 






Taxation

 

-


-



Loss and total other comprehensive expense


(7,351,169)

 

(6,918,131)

 

(13,905,596)

Basic and fully diluted loss per share (US$)

3

(0.035)

 

(0.033)

 

(0.066)

 

 



 

POLAREAN IMAGING PLC

Consolidated unaudited statement of financial position

at 30 June 2023

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

 

 

As at

30 June

2023   

US$

 

As at

30 June

2022
US$

 

As at

31 December 2022

US$

Assets

Note






Non-current assets







Property, plant and equipment


351,109


504,484


418,498

Intangible assets


1,275,465


1,887,717


1,581,591

Right-of-use asset


212,373


336,203


274,288

Trade and other receivables

 

413,539


5,539


437,539

 

 

2,252,486


2,733,943


2,711,916

Current assets

 






Inventories

 

2,061,931


1,571,100


1,711,419

Trade and other receivables

 

1,505,254


1,958,292


1,659,649

Cash and cash equivalents

 

9,879,595


22,690,308


16,454,241


 

13,446,780


26,219,700


19,825,309

Total assets

 

15,699,266

 

28,953,643

 

22,537,225


 






Equity

 






Share capital

4

103,861


103,194


103,463

Share premium

 

59,291,496


59,179,376


59,288,383

Group reorganisation reserve

 

7,813,337


7,813,337


7,813,337

Share-based payment reserve

 

5,299,471


4,362,164


4,865,579

Accumulated losses

 

 

 

 

(60,116,973)


(45,778,339)


(52,765,804)

Total equity

 

12,391,192

 

25,679,732

 

19,304,958


 






Liabilities

 






Non-current liabilities

 






Deferred income

 

99,596


157,702


128,704

Lease liability

5

147,667


285,493


216,691

Trade and other payables

 

300,000


-


360,000

Contingent consideration

 

 

316,000


316,000


316,000


 

863,263


759,195


1,021,395

Current liabilities

 






Trade and other payables

 

2,169,530


2,179,232


1,979,001

Lease liability

5

137,827


144,767


142,146

Deferred income

 

137,454


190,717


89,725


 

2,444,811


2,514,716


2,210,872

Total equity and liabilities

 

 

 

15,699,266

 

28,953,643

 

 

22,537,225

 



POLAREAN IMAGING PLC

Consolidated unaudited statement of changes in equity

at 30 June 2023


 

 

Share capital

 

Share premium

 

Group re-organisation

 

 

Share-based payment reserve

 

 

Accumulated losses

 

 

Total equity

Balance as at 31 December 2021 (audited)

 

101,642

 

59,022,919

 

7,813,337

 

3,660,332

 

(38,860,208)

 

31,738,022

Loss and total comprehensive income for the period

 

-

 

-

 

-

 

-

 

(6,918,131)

 

(6,918,131)

Transactions with owners

 


 

 



Issue of shares

1,552

156,457

-

-

-

158,009

Share-based payments

-

-

-

701,832

-

701,832

Balance as at 30 June 2022 (unaudited)

 

103,194

 

59,179,376

 

7,813,337

 

4,362,164

 

(45,778,339)

 

25,679.732

Comprehensive income

 

 

 

 

 

 

Loss and total comprehensive income for the period

-

-

-

-

(6,987,465)

(6,987,465)

Transactions with owners







Issue of shares

269

109,007

-

-

-

109,276

Share-based payments

-

-

-

503,415

-

503,415

Balance as at 31 December 2022 (audited)

 

103,463

 

59,288,383

 

7,813,337

 

4,865,579

 

(52,765,804)

 

19,304,958

Loss and total comprehensive income for the period

 

-

 

-

 

-

 

-

 

(7,351,169)

 

(7,351,169)

Transactions with owners







Issue of shares

398

3,113

-

-

-

3,511

Share-based payments

-

-

-

433,892

-

433,892

Balance as at 30 June 2023 (unaudited)

 

103,861

 

59,291,496

 

7,813,337

 

5,299,471

 

(60,116,973)

 

12,391,192


 

 





















 

POLAREAN IMAGING PLC

Consolidated unaudited cash flow statement

for the six months ended 30 June 2023


 

 

Unaudited

 

Unaudited

 

Audited


 

 

6 months ended

30 June 2023

US$

6 months ended

30 June 2022

US$

12 months ended

31 December 2022

US$

Cash flows from operating activities

 

 

 

 

Loss for the period before taxation

 

(7,351,169)

(6,918,131)

(13,905,596)

Adjustments for non-cash/non-operating items:





Depreciation of property, plant and equipment


103,594

139,058

277,461

Amortisation of intangible and right-of-use assets


368,041

392,739

760,780

Loss on disposal of property, plant and equipment


-

1,927

2,766

Share based payment expense


433,892

701,832

1,205,247

Net foreign exchange (gains)/losses


(67,685)

228,378

246,309

Finance expense


8,945

12,944

23,762

Finance income


(192,826)

(2,530)

(35,045)



(6,697,208)

(5,443,783)

(11,424,316)

Changes in working capital:





Increase in inventories


(350,512)

(144,290)

(284,609)

Decrease/(increase) in trade and other receivables


57,587

(987,325)

(1,120,681)

Increase in trade and other payables


227,538

435,439

607,887

Increase/(decrease) in deferred revenue


42,421

106,358

Net cash flows used in operating activities


(6,720,174)

(6,033,601)

(12,258,031)






Cash flows from investing activities





Purchase of property, plant and equipment


(36,205)

(10,689)

(63,946)

Interest received


192.826

2,530

35,045

Net cash generated from (used in) investing activities


156,621

(8,159)

(28,901)






Cash flows from financing activities





Issue of shares


3,511

158,009

267,285

Interest paid on lease liabilities


(8,945)

(12,944)

(23,762)

Principal elements of lease payments


(73,344)

(59,527)

(130,949)

Net cash generated from (used in )financing activities


(78,778)

85,538

112,574






Net decrease in cash and equivalents


(6,642,331)

(5,956,222)

(12,174,358)

 





Cash and equivalents at beginning of period


16,454,241

28,874,908

28,874,908

Effect of foreign exchange rate changes on cash





and cash equivalents


67,685

(228,378)

(246,309)

 

Cash and equivalents at end of period


9,879,595

22,690,308

16,454,241

 


 

 

 



NOTES TO THE INTERIM ACCOUNTS


1. Basis of presentation

 

 

This interim consolidated financial information for the six months ended 30 June 2023 has been prepared in accordance with AIM rule 18, 'Half yearly reports and accounts'. This interim consolidated financial information is not the Group's statutory financial statements within the meaning of section 434 of the Companies Act 2006 (and information as required by section 435 of the Companies Act 2006) and should be read in conjunction with the annual financial statements for the year ended 31 December 2022, which have been prepared in accordance with UK-adopted International Accounting Standards (UK IFRS) and have been delivered to the Registrar of Companies. The auditors have reported on those accounts; their report was unqualified but drew attention to a material uncertainty related to going concern. It did not contain statements under section 498(2) or (3) of the Companies Act 2006.

 

The interim consolidated financial information has been prepared in accordance with the accounting policies adopted in the Group's most recent annual financial statements for the year ended 31 December 2022.  A number of amendments to IFRS accounting standards have become applicable for the current reporting period. The Group did not have to change its accounting policies or make retrospective adjustments as a result of adopting these amended standards.

 

The judgements, estimates and assumptions applied in the interim condensed consolidated financial information, including the key sources of estimation uncertainty, were the same as those applied in the Group's last annual financial statements for the year ended 31 December 2022.

 

The interim consolidated financial information for the six months ended 30 June 2023 is unaudited. In the opinion of the Directors, the interim consolidated financial information presents fairly the financial position, and results from operations and cash flows for the period. Comparative numbers for the six months ended 30 June 2022 are also unaudited.

 

This interim consolidated financial information is presented in US Dollars (US$).

 

2. Going concern

 

The interim consolidated financial information for the six months ended 30 June 2023 have been prepared on the going concern basis.

 

In considering the appropriateness of this basis of preparation, the Directors have reviewed the Group's working capital forecasts. It is anticipated that additional capital will need to be raised by the end of the second quarter of 2024 in order to continue to fund the Group's activities at their planned levels beyond this date. This represents a material uncertainty that may cast significant doubt about the Group's and Company's ability to continue as a going concern. However, the Directors have a reasonable expectation that this uncertainty can be managed to a successful outcome, and based on that assessment, the Group has adequate resources to continue for the foreseeable future. Thus, they continue to adopt the going concern basis of accounting in preparing these financial statements.

 

3. Loss per share

 

The basic and diluted loss per share for the period ended 30 June 2023 was US$0.035 (2022: US$0.033) as the warrant and options have an anti-dilutive effect in the current and prior period. The calculation of loss per share is based on the loss of US$7,351,169 for the period ended 30 June 2023 (2022: loss of US$6,918,131) and the weighted average number of shares in issue during the period for calculating the basic loss per share of 213,052,247 shares (2022: 210,921,193).

 

4. Called up share capital

 



Unaudited


Unaudited


Audited

 


30 June 2023

US$


30 June 2022

US$


31 December 2022

US$

Allotted, issued and fully paid







Ordinary Shares


103,861


103,194


103,463

 


 

 

 

 

 

 

 

The number of shares in issue was as follows:

Number of shares

Balance at 1 January 2022

209,249,966

Issued during the period


Exercised options

3,190,024

Balance at 30 June 2022

212,439,990

Issued during the period


Exercised options

607,519

Balance at 31 Dec 2022

213,047,509

Issued during the period


Exercised warrants

852,822

Balance at 30 June 2023

213,900,331

 

 

5. Borrowings



Unaudited


Unaudited


Audited

 


30 June 2023

US$


30 June 2022

US$


31 December 2022

US$

Non-current







Lease liability


147,667


285,493


216,691

 







Current







Lease Liability


137,827


144,767


142,146

Total


285,494


430,260


358,837

 


 

 

 

 

 

 


 

 

 

 

 

6. Share based payments

 

Share Options

The Company grants share options at its discretion to Directors, management and employees. These are accounted for as equity settled transactions. Should the options remain unexercised after a period of ten years from the date of grant the options will expire unless an extension is agreed to by the Board. Options are exercisable at a price equal to the Company's quoted market price on the date of grant or an exercise price to be determined by the Board.

 

Details of share options granted, exercised, forfeited and outstanding in the period ended 30 June 2023 are as follows:

 

 


Number of share options

 

Weighted average exercise price
(US$)

 

Outstanding at 1 January 2023


19,384,571


0.51

Granted during period


5,650,000


0.37

Exercised during period


-


-

Forfeited during period


(329,166)


0.87

Outstanding at 30 June 2023


24,705,405


0.48

Exercisable at 30 June 2023


14,740,960


0.37

 

There were 5,650,000 options granted in the period to 30 June 2023. There were no options exercised and 329,166 options forfeited in the period to 30 June 2023.

 

The weighted average contractual life of the share options outstanding at the reporting date is 5 years and 84 days.

 

Share Warrants

The Company grants share warrants at its discretion to Directors, management, employees, advisors and lenders. These are accounted for as equity settled transactions. Terms of warrants vary from agreement to agreement.

 

Details of warrants granted, exercised, forfeited and outstanding in the period ended 30 June 2023 are as follows:

 

 


Number of
share warrants

 

Weighted average exercise price (US$)

Outstanding at 1 January 2023


3,054,129


0.01000

Exercised during the period


(852,822)


0.00412

Forfeited during the period


(3,400)


0.18000

Outstanding at 30 June 2023


2,197,907

 

0.02000

Exercisable at 30 June 2023


2,197,907

 

0.02000

 

There were 852,822 warrants exercised and 3,400 warrants forfeited in the six months ended 30 June 2023. There were no warrants granted during this period.

 

The weighted average contractual life of the share warrants outstanding at the reporting date is 1 year and 180 days.

 

 

7. Related party transactions

 

The Company paid US$11,650 of consulting fees to board member Daniel Brague in the six months ending 30 June 2023. 

 

 

8. Events after the reporting period

 

On 4 August 2023, the Company issued a total of 1,948,262 shares upon the exercise of warrants with an exercise price of US$0.00749 per share for total proceeds of US$14,583.

 

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