TIDMPOLX
RNS Number : 4985A
Polarean Imaging PLC
30 September 2020
Polarean Imaging Plc
("Polarean" or the "Company")
Half-year Report
Polarean Imaging plc (AIM: POLX), the medical-imaging technology
company, with a proprietary investigational drug-device combination
diagnostic for magnetic resonance imaging ("MRI"), announces its
unaudited interim results for the six months ended 30 June 2020
.
Highlights
-- Positive results from Phase III trials (the "Clinical Trials") announced in January 2020
-- Raised gross proceeds of GBP8.4m in April 2020, which
included a GBP2.2m subscription from new strategic investor Bracco
Imaging S.p.A. ("Bracco")
-- Appointment of former NED Jonathan Allis as Chairman in February 2020
-- Appointment of Cyrille Petit as Non-Executive Director and
representative of Bracco in June 2020
-- Net cash of US$9.2m as of 30 June 2020
Post-period end
-- Significant progress toward submission of New Drug Application ("NDA")
- Small Business Waiver of Human Drug Application Fee granted by
the United States Food and Drug Administration ("FDA") on 28
September 2020
- NDA to be submitted in early October 2020
-- Presentation of data at the American Thoracic Society and the
International Society for Magnetic Resonance in Medicine virtual
conferences
-- Installed a 9820 Xenon Polariser system at University of
Kansas Medical Center ("KU Medical Center")
-- Government COVID-19-related grants are being applied for and
received by our current device users, including a recent award for
a multi-center initiative coordinated by Western Ontario Professor
Grace Parraga PhD to better understand the long-term effects of
COVID-19 using hyperpolarised 129Xe MRI in combination with
computed tomography (CT)
Richard Hullihen, CEO of Polarean, commented: "During the period
under review, Polarean achieved one of its most important
milestones to date, the positive readout from our Phase III
Clinical Trials. We subsequently undertook an GBP8.4m fundraising
and welcomed our new strategic investor Bracco to our share
register, alongside several new institutional investors. We are
also grateful for the continued support we received from our
existing long-term investors and partners. The installation of new
polarisers has continued and users of our systems are publishing
research at an increased rate, expanding and deepening the
knowledge base of the use of hyperpolarised 129Xe in pulmonary
medicine, while further validating Polarean's technology. We look
forward to providing our shareholders with updates regarding
further progress and specifically the imminent submission of the
Company's NDA to the FDA."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Enquiries:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Officer Via Walbrook PR
Jonathan Allis, Chairman
SP Angel Corporate Finance LLP Tel: +44 (0)20 3470 0470
David Hignell / Soltan Tagiev (Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
Walbrook PR Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
Paul McManus / Anna Dunphy Mob: +44 (0)7980 541 893 / +44 (0)7876 741 001
About Polarean ( www.polarean.com )
The Company and its wholly owned subsidiary, Polarean, Inc.
(together the "Group") are revenue generating, medical drug-device
combination companies operating in the high resolution medical
imaging market.
The Group develops equipment that enables existing MRI systems
to achieve an improved level of pulmonary function imaging and
specialises in the use of hyperpolarised Xenon gas ((129) Xe) as an
imaging agent to visualise ventilation and gas exchange regionally
in the smallest airways of the lungs, the tissue barrier between
the lung and the bloodstream and in the pulmonary vasculature.
Xenon gas exhibits solubility and signal properties that enable it
to be imaged within other tissues and organs.
The Group operates in an area of significant unmet medical need
and the Group's technology provides a novel diagnostic approach,
offering a non-invasive and radiation-free functional imaging
platform which is more accurate and less harmful to the patient
than current methods. The annual burden of pulmonary disease in the
US is estimated to be over US$150 billion.
The Group also develops high performance MRI radiofrequency (RF)
coils which are a required component for imaging (129) Xe in the
MRI system. The development of these coils by the Group facilitates
the adoption of the Xenon technology by providing
application-specific RF coils which optimise the imaging of (129)
Xe in MRI equipment for use as a medical diagnostic as well as a
method of monitoring the efficacy of therapeutic intervention.
CEO Statement
Introduction
The six month period ending 30 June 2020 has seen Polarean make
substantial progress towards its goal of seeking FDA approval for
the Company's drug-device combination. After successfully
completing two Phase III Clinical Trials in Q4 2019, the Company
announced positive top line results of these Clinical Trials on 29
January 2020. During the first half of 2020, the Company performed
the post trial in depth analysis of the results of the Clinical
Trials and initiated work associated with the construction of both
the drug and device components of our NDA submission.
Despite the challenging market conditions in the first half of
2020, the Company closed a financing that resulted in gross
proceeds of US$10.4m (GBP8.4m). This financing included a new
strategic investor, Bracco Imaging S.p.A., several new
institutional investors and the continued support of previous VCT
and EIS investors. We are encouraged with the support shown by new
and existing shareholders and these additional funds will further
support our preparation of our NDA for submission to the FDA, focus
on preparations for commercial launch and continue development of
our polariser system.
Also, during the period, former NED Jonathan Allis was appointed
Chairman of Polarean after the sale of his former company, Blue
Earth Diagnostics, to Bracco. We also welcomed Cyrille Petit to the
Board, as a result of the Bracco investment.
Results overview
Group revenues for the first half were US$0.3m (2019: US$0.4m)
and were largely derived from our collaboration with the University
of Cincinnati where work under our SBIR grant has been completed.
We continue to sell our polariser systems on a research-use-only
basis to academic institutions in the US, Canada and Europe. Due to
COVID-19, we were unable to complete the installation of a
polariser system we had delivered to KU Medical Center during
December 2019. The system installation completed recently as per
the Company's announcement on 18 September 2020. Operating expenses
for H1 2020 (US$3.4m) were flat compared with H1 2019 (US$3.4m), as
Administrative Expenses (H1 2020 US$2.7m, H1 2019 US $3.1m)
decreased after we completed the Clinical Trials and Selling and
Distribution Expenses (H1 2020 US$0.4m, H1 2019 US $0.1m) increased
as we began preparations for commercial launch. During H1 2020, the
Company received a US$0.3m forgivable loan under the US Paycheck
Protection Program ("PPP"), which was recognised as Finance Income.
Our overall loss before tax decreased from US$3.4m to US$3.2m in
the same comparable period, due to the PPP proceeds. The Company
completed the GBP8.4m fundraise during H1 2020 via the issue of new
equity and as at 30 June 2020 we held US US$9.2m in net cash or
cash equivalents.
Post-period end events
Presentation at Medical Conferences and Studies Utilising our
Technology
The Company's technology was prominent at the American Thoracic
Society and International Society of Magnetic Resonance in Medicine
virtual conferences during August 2020. Over 40 abstracts related
to the use of hyperpolarised (129) Xe were presented at the two
conferences, including the Company's Clinical Trial results. The
content of our publications and those of our customers, along with
our participation is available on our website at www.polarean.com .
The users of our polarisers continue to expand and document the
applications of our technology across the spectrum of pulmonary
disease.
The " (129) Xe MRI Clinical Trials Consortium" continues to
discuss the application of our technology to the case of post
infection COVID-19 patients to assess the long-term effects and
case management of these patients. Investigator-initiated
government research grants have been submitted to study the use of
our technology to assess the long-term effects of COVID-19 post
infection in patients. Some of these grants have been awarded and
COVID-19-related clinical research has begun.
Installation of Xenon Polarisers
Whilst we seek clinical approval for our medical drug-device
combination we continue to expand our installed base of systems
through additional sales of research units to academic
institutions. We recently completed the installation of a new
system at the KU Medical Center, which is starting up a research
programme under the guidance of a veteran researcher in the field
of hyperpolarised 129Xe imaging.
Researchers continue to apply for and receive grants to purchase
our polariser systems. We are in discussions with several potential
customers and anticipate additional orders during calendar year
2020. The number of systems currently installed is 23.
NDA Submission
We have continued to compile the components of the NDA
submission. On 28 September 2020, the Company was granted a Small
Business Waiver of Human Drug Application Fee (the "Waiver") by the
FDA. The Waiver exempts the Company from having to pay the US$2.9m
filing fee for our NDA submission. We anticipate submitting our NDA
to the FDA in early October 2020.
Outlook
We continue to demonstrate that Polarean's technology has the
potential to be of tremendous benefit to patients and a powerful
new tool for clinicians in discovering and characterising treatable
traits in pulmonary medicine. In addition, our latest new
techniques lead us into the field of cardiology and pulmonary
vascular disease which is one example of the further potential of
our technology. We also look forward to evaluating new uses of our
technology in pharmaceutical drug development. There are currently
40 clinical trials ongoing into the use of (129) Xe MRI according
to the FDA website.
The burden of pulmonary disease in the USA is approximately
US$150bn and is widespread and growing, affecting nearly 40 million
Americans. Given the limitations of existing methods of diagnosis
and lung disease monitoring, we estimate that there is a
significant unmet need for non-invasive, quantitative, and
cost-effective image-based diagnosis technology. We believe that
our unique medical drug-device combination utilising 129Xe offers
the ideal solution for improving pulmonary disease diagnosis.
This is an exciting time for the Company, as we enter the final
stages of submitting our NDA and look towards a potential
commercial launch before the end of 2021.
Richard Hullihen
Chief Executive Officer
30 September 2020
POLAREAN IMAGING PLC
Consolidated unaudited statement of comprehensive income
for the six months ended 30 June 2020
Unaudited Unaudited Audited
6 months 6 months 12 months
ended 30.6.20 ended 30.6.19 ended 31.12.19
US$ US$ US$
Note
Revenue 327,896 399,639 2,301,093
Cost of sales (41,387) (75,185) (925,612)
--------------- --------------- ----------------
Gross profit 286,509 324,454 1,375,481
Administrative expenses (2,724,411) (3,068,371) (6,010,119)
Depreciation (73,204) (4,661) (63,121)
Amortisation (359,677) (341,937) (683,873)
Selling and distribution expenses (351,754) (147,821) (324,791)
Share based payment expense (213,906) (139,886) (305,747)
--------------- --------------- ----------------
Loss from operations (3,436,443) (3,378,222) (6,012,170)
Finance expense (9,647) (22,356) (91,678)
Finance income 267,155 274 508
--------------- --------------- ----------------
Loss on ordinary activities
before taxation 3 (3,178,935) (3,400,304) (6,103,340)
Taxation - - -
--------------- --------------- ----------------
Loss and total other comprehensive
expense (3,178,935) (3,400,304) (6,103,340)
Basic and fully diluted loss
per share (US$) 3 (0.023) (0.034) (0.057)
POLAREAN IMAGING PLC
Consolidated unaudited statement of financial position
at 30 June 2020
Unaudited Unaudited Audited
As at 30.6.20 As at 30.6.19 As at 31.12.19
US$ US$ US$
Assets Note
Non-current assets
Property, plant and equipment 312,287 13,091 355,958
Intangible assets 3,119,120 3,735,973 3,427,547
Right-of-use asset 224,414 131,773 98,263
Trade and other receivables 5,539 5,539 5,539
-------------- -------------- ---------------
3,661,360 3,886,376 3,887,307
Current assets
Inventories 950,674 1,233,039 554,211
Trade and other receivables 522,625 1,094,988 636,783
Cash and cash equivalents 9,190,862 1,277,195 1,961,869
-------------- -------------- ---------------
10,664,161 3,605,222 3,152,863
-------------- -------------- ---------------
Total assets 14,325,521 7,491,598 7,040,170
-------------- -------------- ---------------
Equity
Share capital 4 77,518 49,767 55,776
Share premium 23,573,058 11,200,461 13,659,912
Group reorganisation reserve 7,813,337 7,813,337 7,813,337
Share-based payment reserve 1,584,640 1,218,221 1,370,734
Accumulated losses (21,488,616) (15,619,993) (18,309,681)
-------------- -------------- ---------------
Total equity 11,559,937 4,661,793 4,590,078
Liabilities
Non-current liabilities
Deferred income 192,817 87,029 192,817
Lease liability 5 149,487 83,168 50,455
Contingent consideration 316,000 316,000 316,000
-------------- -------------- ---------------
658,304 486,197 559,272
Current liabilities
Trade and other payables 1,985,828 1,604,792 1,773,582
Lease liability 5 102,213 82,716 70,914
Deferred income 19,239 656,100 46,324
-------------- -------------- ---------------
2,107,280 2,343,608 1,890,820
-------------- -------------- ---------------
Total equity and liabilities 14,325,521 7,491,598 7,040,170
-------------- -------------- ---------------
POLAREAN IMAGING PLC
Consolidated unaudited statement of changes in equity
at 30 June 2020
Share-based
Share Group payment Accumulated
capital Share premium re-organisation reserve losses Total equity
--------- --------------- -------------------- ------------- -------------- --------------
Balance as at 31
December 2018
(audited) 49,427 11,063,075 7,813,337 1,078,335 (12,212,767) 7,791,407
Change in accounting
policy - - - - (6,922) (6,922)
Restated total equity
at 1 January 2019 49,427 11,063,075 7,813,337 1,078,335 (12,219,689) 7,784,485
--------- --------------- -------------------- ------------- -------------- --------------
Loss and total
comprehensive
income for the
period - - - - (3,400,304) (3,400,304)
Issue of shares 340 137,386 - - - 137,726
Share-based payments - - - 139,886 - 139,886
--------- --------------- -------------------- ------------- -------------- --------------
Balance as at 30
June 2019
(unaudited) 49,767 11,200,461 7,813,337 1,218,221 (15,619,993) 4,661,793
Comprehensive income
Share based payment
- lapsed share
options - - - (13,348) 13,348 -
Loss and total
comprehensive
income for the
period - - - - (2,703,036) (2,703,036)
Transaction with
owners
Issue of shares 6,009 2,618,903 - - - 2,624,912
Share issue costs - (159,452) - - - (159,452)
Share-based payments - - - 165,861 - 165,861
Balance as at 31
December 2019
(audited) 55,776 13,659,912 7,813,337 1,370,734 (18,309,681) 4,590,078
--------- --------------- -------------------- ------------- -------------- --------------
Loss and total
comprehensive
income for the
period - - - - (3,178,935) (3,178,935)
Issue of shares 21,742 10,427,537 - - - 10,449,279
Share issue costs - (514,391) - - - (514,391)
Share-based payments - - - 213,906 - 213,906
Balance as at 30
June 2020
(unaudited) 77,518 23,573,058 7,813,337 1,584,640 (21,488,616) 11,559,937
========= =============== ==================== ============= ============== ==============
POLAREAN IMAGING PLC
Consolidated unaudited cash flow statement
for the six months ended 30 June 2020
Unaudited Unaudited Audited
6 months 6 months 12 months
ended 30.6.20 ended 30.6.19 ended
US$ US$ 31.12.19
US$
Cash flows from operating activities
Loss for the period before taxation (3,178,935) (3,400,304) (6,103,340)
Adjustments for non-cash/non-operating
items:
Depreciation of plant and equipment 73,204 4,661 63,121
Amortisation of intangible assets 359,677 341,937 683,873
Share based compensation 213,906 139,886 305,747
Interest paid - 22,356 91,678
Interest received (92) (274) (508)
(2,532,240) (2,891,738) (4,959,429)
Changes in working capital:
Increase in inventories (396,462) (581,257) (97,570)
Increase in trade and other receivables 114,157 (301,448) (14,737)
(Decrease)/increase in trade and
other payables 189,407 36,955 (285,074)
Increase/(decrease) in deferred
revenue (27,085) 617,575 595,961
--------------- --------------- ------------
Net cash flows used from operating
activities (2,652,223) (3,119,913) (4,565,709)
Cash flows from investing activities
Purchase of plant and equipment (29,534) - (401,327)
--------------- --------------- ------------
Net cash used in investing activities (29,534) - (401,327)
Cash flows from financing activities
Issue of shares 10,449,279 3,577,509 6,373,919
Cost of issue (514,391) (159,452)
Interest paid - (22,356) -
Interest received 92 274 508
Funds received from PPP loan 22,840 - -
Principal elements of lease payments (56,717) (42,793) (69,993)
Interest elements of lease payments 9,647 8,873 (91,678)
--------------- --------------- ------------
Net cash generated from financing
activities 9,910,750 3,521,507 6,053,304
Net increase in cash and equivalents 7,228,993 404,594 (1,086,268)
Cash and equivalents at beginning
of period 1,961,869 875,601 875,601
Cash and equivalents at end of
period 9,190,862 1,277,195 1,961,869
NOTES TO THE INTERIM ACCOUNTS
1. Basis of preparation
The accounting policies adopted are consistent with those of the
previous financial year ended 31 December 2019.
This interim consolidated financial information for the six
months ended 30 June 2020 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 2019,
which have been prepared in accordance with International Financial
Reporting Standards (IFRS) and have been delivered to the Registrar
of Companies. The auditors have reported on those accounts; their
report was unqualified, did not include references to any matters
to which the auditors drew attention by way of emphasis of matter
without qualifying their report and did not contain statements
under section 498(2) or (3) of the Companies Act 2006.
The interim consolidated financial information for the six
months ended 30 June 2020 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 2019 are also unaudited.
This interim consolidated financial information is presented in
US Dollars ($).
2. Going concern
The interim consolidated financial information for the six
months ended 30 June 2020 have been prepared on the going concern
basis.
The Directors consider the going concern basis of preparation to
be appropriate in preparing the financial statements. In
considering the appropriateness of this basis of preparation, the
Directors have received the Group's working capital forecasts for a
minimum of 12 months from the date of the approval of this
financial information. Based on their consideration the Directors
have reasonable expectation that the Group has adequate resources
to continue for the foreseeable future and that carrying values of
intangible assets are supported. Thus, they continue to adopt the
going concern basis of accounting in preparing this financial
information.
3. Loss per share
The basic and diluted loss per share for the period ended 30
June 2020 was US$0.023 (2019: US$0.034) The calculation of loss per
share is based on the loss of US$3,178,935 for the period ended 30
June 2020 (2019: loss of US$3,400,304) and the weighted average
number of shares in issue during the period for calculating the
basic profit per share of 137,598,239 shares (2019:
101,087,330).
4. Called up share capital
Unaudited Unaudited Audited
30.6.20 30.6.19 31.12.19
US$ US$ US$
Allotted, issued and fully paid
Ordinary Shares 77,518 49,427 55,776
---------- ---------- ---------
The number of shares in issue was as follows: Number of shares
Balance at 1 January 2019 100,730,893
Exercised warrants 705,040
-----------------
Balance at 30 June 2019 101,435,933
Issued during the period 11,666,667
Exercised warrants 1,336,000
-----------------
Balance at 31 Dec 2019 114,438,600
Issued during the period 46,624,997
Exercised warrants 766,410
-----------------
Balance at 30 June 2020 161,830,007
-----------------
5. Borrowings
Unaudited Unaudited Audited
30.6.20 30.6.19 31.12.19
US$ US$ US$
Non-current
Lease liability 149,487 83,168 50,455
---------- ---------- ---------
Current
Bank Overdraft - 8,443 -
Lease Liability 102,213 74,273 70,917
---------- ---------- ---------
Total 251,700 82,716 121,369
---------- ---------- ---------
6. Share based payments
Share Options
The Company grants share options as 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 at the year-end are as follows:
Number of share options Weighted average exercise price
(US$)
Outstanding at 1 January 2020 17,436,722 0.15
Outstanding at 30 June 2020 17,436,722 0.15
-------------------------------- ------------------------ --------------------------------
Exercisable at 30 June 2020 9,383,074 0.10
-------------------------------- ------------------------ --------------------------------
There have been no options granted in the period to 30 June
2020.
The weighted average contractual life of the share options
outstanding at the reporting date is 6 years and 278 days.
Share Warrants
The Company grants share warrants at its discretion to
Directors, management, employees, advisors and lenders. These are
accounted for as equity settled transactions. Terms of warrants
vary from agreement to agreement.
Details for the warrants exercised, lapsed and outstanding at
the period ending 30 June 2020 are as follows:
Number of Weighted average exercise price (US$)
share warrants
Outstanding at 1 January 2020 4,824,703 0.09
Exercised during the period (766,410) 0.10
Outstanding at 30 June 2020 4,058,293 0.09
-------------------------------- ---------------- --------------------------------------
Exercisable at 30 June 2020 4,058,293 0.09
-------------------------------- ---------------- --------------------------------------
On 2 March 2020, 232,010 new ordinary shares were issued by the
Company following the exercise of warrants at an exercise price of
0.037 pence per warrant. On 1 June 2020, the Company issued a
further 534,400 new ordinary shares following an exercise of
warrants at an exercise price of 0.003 pence per warrant.
The weighted average contractual life of the share warrants
outstanding at the reporting date is 3 years and 99 days.
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END
IR BLGDCLSDDGGC
(END) Dow Jones Newswires
September 30, 2020 02:00 ET (06:00 GMT)
Polarean Imaging (LSE:POLX)
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