TIDMPOLX
RNS Number : 4465K
Polarean Imaging PLC
02 September 2021
Polarean Imaging Plc
("Polarean" or the "Company")
Half-year Report
Polarean Imaging plc (AIM: POLX), the medical - imaging
technology company, with an investigational drug - device
combination product for magnetic resonance imaging (MRI), announces
its unaudited interim results for the six months ended 30 June 2021
.
Highlights
-- Raised GBP27 million gross proceeds in an oversubscribed
financing, 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.
-- Appointment of Chief Financial Officer, Chuck Osborne, to the Board
-- Additional research unit order for a 9820 Xenon Polariser
system from the University of British Columbia in Vancouver,
Canada
-- Installation of its 9820 Xenon Polariser system for the
University of Texas MD Anderson Cancer Center
-- Presentation of data at both the American Thoracic Society
("ATS") and the International Society for Magnetic Resonance in
Medicine ("ISMRM") virtual conferences
-- Publication of first peer reviewed COVID-19 research by
Professor Fergus Gleeson at the University of Oxford
-- Net cash of US$38.2m as of 30 June 2021
Post-period end
-- Frequent interactions with the FDA as they review the NDA in
advance of our target PDUFA goal date of 5 October 2021
-- Preparation for launch of product including recruitment of
employees into our sales and marketing organization
-- Planning to broaden the awareness of Polarean technology
through exhibitions at CHEST and RSNA 2021 and numerous topical
conferences
Richard Hullihen, CEO of Polarean, commented : "During the first
half of 2021 the Company raised its largest financing to date with
its oversubscribed GBP27 million gross proceeds financing. We
appreciate the continued support from our existing strategic,
institutional and retail investors and welcome several new
significant institutional investors. The proceeds from this round
are being used to plan and execute the launch of our product in
accordance with our current target PDUFA date of 5 October 2021. We
continue to sell new polarisers systems for research use, as the
amount of polarised Xenon research continues to increase. We look
forward to providing our shareholders with updates regarding
further progress and specifically the status of our target PDUFA
date of 5 October 2021, and we thank them for their continued
support on this exciting journey."
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
Richard Hullihen, Chief Executive Officer Via Walbrook PR
Jonathan Allis, Chairman
Stifel Nicolaus Europe Limited (NOMAD and
Sole Corporate Broker)
Nicholas Moore / Ben Maddison / Samira Essebiyea
(Healthcare +44 (0)20 7710
Investment Banking) 7600
Nick Adams / Fred Walsh (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)7879 741
001
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 ((129) Xe) as an
imaging agent to visualise ventilation. (129) Xe gas is currently
being studied for visualisation of gas exchange regionally in the
smallest airways of the lungs, across the alveolar tissue barrier,
and into the pulmonary bloodstream.
In October 2020, the Group submitted a New Drug Application
("NDA") to the FDA for hyperpolarised (129) Xe used to evaluate
pulmonary function and to visualise the lung using MRI. In December
2020, the Group received confirmation of acceptance of its NDA by
the FDA, with a target PDUFA action date of 5 October 2021.
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. The annual burden of pulmonary disease
in the US is estimated to be over US$150 billion.
CEO Statement
Introduction
The six month period ending 30 June 2021 has seen Polarean make
substantial progress towards its goal of seeking FDA approval for
the Company's drug-device combination. As in the normal course,
post submission, the Company has responded to the question and
answer process with the FDA for our submission, while preparing
itself and verifying the preparation of its suppliers and
providers.
In January, the Company appointed a new Nominated Advisor and
Broker, Stifel Nicolaus Europe Limited, which led to a successful
placing, subscription, and open offer which was oversubscribed in
every category, including its strategic investors Nukem Isotopes
and Bracco. Then in February, Chuck Osborne, the existing CFO, was
appointed to the Board in order to further leverage his extensive
experience in early-stage life science company management, build
out and fund raising.
During challenging times in healthcare and hospital utilization,
we continued to take research orders from leading academic centres
such as BC Children's hospital in Vancouver and also to build and
deliver systems, completing the installation at MD Anderson Cancer
Center in Houston.
Presentation at Medical Conferences and Studies Utilising our
Technology
The Company's technology was once again prominent at the ATS and
ISMRM virtual conference during May 2021 with over 50 abstracts
related to the use of hyperpolarised (129) Xe accepted for
presentation at the two conferences. The content of our
publications and those of our customers, along with our
participation is available on our website at www.polarean.com. The
user base of our polarisers continues to expand and document the
applications of our technology across the spectrum of pulmonary
disease.
Importantly, the first peer reviewed article on COVID-19 Long
Haul patients visualised using (129) Xe have now been published (
https://pubs.rsna.org/doi/10.1148/radiol.2021210033 ). Additional i
nvestigator-initiated government research grants are underway to
study the use of our technology to assess the long-term effects of
COVID-19 infection in patients.
Results overview
Group revenues for the first half were US$0.6m (2020: US$0.3m)
and were largely derived from the sale of a polariser system to MD
Anderson, in contrast to the H1 2020 revenue, which was largely
from our collaboration with the University of Cincinnati for work
under our SBIR grant, which has now been completed. We continue to
sell our polariser systems on a research-use-only basis to academic
institutions in the US, Canada and Europe. Operating expenses for
H1 2021 (US$5.5m) increased from H1 2020 (US$3.4m), as Selling and
Distribution Expenses (H1 2021 US$1.8m, H1 2020 US $0.4m) increased
as we are executing our plans for commercial launch. During H1
2021, the Company recognized Finance Income of US$0.4m due to the
strengthening of the British pound, which more than offset the
US$0.3m forgivable loan under the US Paycheck Protection Program
("PPP") we received and recognized as Finance Income in H1 2020.
Our overall loss before tax increased from US$3.2m to US$4.9m in
the same comparable period, due primarily to the commercial launch
preparation expenses. The Company completed a GBP27m ($37m)
fundraise during H1 2021 via the issue of new equity and as at 30
June 2021 we held US US$38.2m in net cash or cash equivalents.
Post-period end events
FDA review of NDA
We continue to interact with the FDA as they review our NDA with
a target date PDUFA date of 5 October 2021.
Preparation for launch
We continue to prepare for the potential launch of our drug
device combination post FDA approval. In particular, we have been
building a sales and marketing organization with the recent
recruitment of several sales positions.
Planning for conference exhibitions
We are continuing to increase the awareness of Polarean
technology with exhibitions at CHEST in October 2021 and RSNA in
December 2021.
Research polarisers
Researchers continue to apply for and receive grants to purchase
our polariser systems, most recently BC Children's Hospital in
Vancouver, BC. This system has been delivered and is proceeding to
installation. We are in discussions with several research
institutions and anticipate additional possible orders during
calendar year 2021.
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.
The burden of pulmonary disease in the USA is approximately
US$150bn and is widespread and growing, affecting nearly 40 million
Americans and 500 million worldwide, with post COVID patients
comprising a new segment approaching the scale of asthma. Given the
limitations of existing methods of diagnosis and lung disease
monitoring, we estimate that there is a significant unmet need for
safe, non-invasive, quantitative, and cost-effective image-based
diagnosis technology. We believe that our unique medical
drug-device combination utilising 129Xe offers the ideal solution
for improving pulmonary disease diagnosis.
This is an exciting time for the Company, as we enter the final
stages of submitting our NDA and look towards a potential
commercial launch before the end of 2021.
Richard Hullihen
Chief Executive Officer
2 September 2021
POLAREAN IMAGING PLC
Consolidated unaudited statement of comprehensive income
for the six months ended 30 June 2021
Unaudited Unaudited Audited
6 months 6 months 12 months
ended 30.6.21 ended 30.6.20 ended 31.12.20
US$ US$ US$
Note
Revenue 621,874 327,896 1,056,766
Cost of sales (323,185) (41,387) (346,300)
--------------- --------------- ----------------
Gross profit 298,689 286,509 710,466
Administrative expenses (2,915,214) (2,724,411) (5,049,246)
Depreciation (81,320) (73,204) (150,224)
Amortisation (375,861) (359,677) (734,058)
Selling and distribution expenses (1,799,324) (351,754) (917,783)
Share based payment expense (367,397) (213,906) (474,716)
--------------- --------------- ----------------
Loss from operations (5,240,427) (3,436,443)) (6,615,562)
Finance expense (8,261) (9,647) (19,730)
Finance income 393,392 267,155 100,769
--------------- --------------- ----------------
Loss on ordinary activities
before taxation 3 (4,855,296) (3,178,935) (6,534,523)
Taxation - - -
--------------- --------------- ----------------
Loss and total other comprehensive
expense (4,855,296) (3,178,935) (6,534,523)
Basic and fully diluted loss
per share (US$) 3 (0.026) (0.023) (0.044)
POLAREAN IMAGING PLC
Consolidated unaudited statement of financial position
at 30 June 2021
Unaudited Unaudited Audited
As at 30.6.21 As at 30.6.20 As at 31.12.20
US$ US$ US$
Assets Note
Non-current assets
Property, plant and equipment 233,044 312,287 271,264
Intangible assets 2,502,268 3,119,120 2,810,694
Right-of-use asset 116,778 224,414 184,213
Trade and other receivables 5,539 5,539 5,539
-------------- -------------- ---------------
2,857,629 3,661,360 3,271,710
Current assets
Inventories 1,246,311 950,674 977,924
Trade and other receivables 397,473 522,625 348,067
Cash and cash equivalents 38,197,203 9,190,862 6,282,665
-------------- -------------- ---------------
39,840,987 10,664,161 7,608,656
-------------- -------------- ---------------
Total assets 42,698,616 14,325,521 10,880,366
-------------- -------------- ---------------
Equity
Share capital 4 101,545 77,518 78,200
Share premium 59,003,465 23,573,058 23,840,571
Group reorganisation reserve 7,813,337 7,813,337 7,813,337
Share-based payment reserve 2,212,848 1,584,640 1,845,450
Accumulated losses (29,699,500) (21,488,616) (24,844,204)
-------------- -------------- ---------------
Total equity 39,431,695 11,559,936 8,733,354
Liabilities
Non-current liabilities
Deferred income 219,954 192,817 219,954
Lease liability 5 21,017 149,487 91,609
Contingent consideration 316,000 316,000 316,000
-------------- -------------- ---------------
556,971 658,304 627,563
Current liabilities
Trade and other payables 2,549,096 1,985,828 1,348,866
Lease liability 5 137,589 102,213 129,819
Deferred income 23,265 19,239 40,763
-------------- -------------- ---------------
2,709,950 2,107,280 1,519,449
-------------- -------------- ---------------
Total equity and liabilities 42,698,616 14,325,521 10,880,366
-------------- -------------- ---------------
POLAREAN IMAGING PLC
Consolidated unaudited statement of changes in equity
at 30 June 2021
Share-based
Share Group payment Accumulated
capital Share premium re-organisation reserve losses Total equity
--------- --------------- -------------------- ------------- -------------- --------------
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
Comprehensive income
Loss and total
comprehensive
income for the
period - - - - (3,355,588) (3,355,588)
Transactions with
owners
Issue of shares 682 275,836 - - - 276,518
Share issue costs - (8,323) - - - (8,323)
Share-based payments - - - 260,810 - 260,810
Balance as at 31
December 2020
(audited) 78,200 23,840,571 7,813,337 1,845,450 (24,844,204) 8,733,354
--------- --------------- -------------------- ------------- -------------- --------------
Loss and total
comprehensive
income for the
period - - - - (4,855,296) (4,855,296)
Issue of shares 23,345 37,260,511 - - - 37,283,856
Share issue costs - (2,097,617) - - - (2,097,617)
Share-based payments - - - 367,398 - 367,398
Balance as at 30
June 2021
(unaudited) 101,545 59,003,465 7,813,337 2,212,848 (29,699,500) 39,431,695
========= =============== ==================== ============= ============== ==============
POLAREAN IMAGING PLC
Consolidated unaudited cash flow statement
for the six months ended 30 June 2021
Unaudited Unaudited Audited
6 months 6 months 12 months
ended 30.6.21 ended 30.6.20 ended
US$ US$ 31.12.20
US$
Cash flows from operating activities
Loss for the period before taxation (4,855,296) (3,178,935) (6,534,522)
Adjustments for non-cash/non-operating
items:
Depreciation of plant and equipment 81,320 73,204 150,224
Amortisation of intangible assets 375,861 359,677 734,058
Share based compensation 367,398 213,906 474,716
Interest paid - - 19,730
Interest received (470) (92) (100,769)
(4,031,187) (2,532,240) (5,256,563)
Changes in working capital:
Increase in inventories (268,387) (396,462) (423,093)
Increase in trade and other receivables (49,406) 114,157 288,096
Increase/(decrease) in trade and
other payables 1,310,426 189,407 (424,714)
Increase/(decrease) in deferred
revenue (127,696) (27,085) 21,576
--------------- --------------- ------------
Net cash flows used from operating
activities (3,166,250) (2,652,223) (5,794,698)
Cash flows from investing activities
Purchase of plant and equipment (43,099) (29,534) (65,531)
--------------- --------------- ------------
Net cash used in investing activities (43,099) (29,534) (65,531)
Cash flows from financing activities
Issue of shares 37,283,856 10,449,279 10,725,797
Cost of issue (2,097,617) (514,391) (522,714)
Interest paid - - -
Interest received 470 92 100,769
Funds received from PPP loan - 22,840 -
Principal elements of lease payments (71,083) (56,717) (103,097)
Interest elements of lease payments 8,261 9,647 (19,730)
--------------- --------------- ------------
Net cash generated from financing
activities 35,123,887 9,910,750 10,181,025
Net increase in cash and equivalents 31,914,538 7,228,993 4,320,796
Cash and equivalents at beginning
of period 6,282,665 1,961,869 1,961,869
Cash and equivalents at end of
period 38,197,203 9,190,862 6,282,665
NOTES TO THE INTERIM ACCOUNTS
1. Basis of presentation
The accounting policies adopted are consistent with those of the
previous financial year ended 31 December 2020.
This interim consolidated financial information for the six
months ended 30 June 2021 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 2020,
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 2021 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 2020 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 2021 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 2021 was US$0.026 (2020: US$0.023) The calculation of loss per
share is based on the loss of US$4,855,296 for the period ended 30
June 2021 (2020: loss of US$3,178,935) and the weighted average
number of shares in issue during the period for calculating the
basic profit per share of 184,552,681 shares (2020:
137,598,239).
4. Called up share capital
Unaudited Unaudited Audited
30.6.21 30.6.20 31.12.20
US$ US$ US$
Allotted, issued and fully paid
Ordinary Shares 101,545 77,518 78,200
---------- ---------- ---------
The number of shares in issue was as follows: Number of shares
Balance at 1 January 2020 114,438,600
Issued during the period 11,666,667
Exercised warrants 766,410
-----------------
Balance at 30 June 2020 161,830,007
Issued during the period 1,318,800
Exercised warrants 64,128
-----------------
Balance at 31 Dec 2020 163,212,935
Issued during the period 44,932,142
Exercised warrants 928,089
-----------------
Balance at 30 June 2021 209,073,166
-----------------
5. Borrowings
Unaudited Unaudited Audited
30.6.21 30.6.20 31.12.20
US$ US$ US$
Non-current
Lease liability 21,017 149,487 91,609
---------- ---------- ---------
Current
Lease Liability 137,589 102,213 129,819
---------- ---------- ---------
Total 158,606 251,700 221,428
---------- ---------- ---------
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$)
Outstanding at 1 January 2021 16,884,322 0.19
Granted during period 1,250,000 1.12
Outstanding at 30 June 2021 18,134,322 0.26
-------------------------------- ------------------------ --------------------------------
Exercisable at 30 June 2021 12,699,615 0.14
-------------------------------- ------------------------ --------------------------------
There were 1,250,000 options granted in the period to 30 June
2021. No options were exercised or forfeited during the period.
The weighted average contractual life of the share options
outstanding at the reporting date is 4 years and 361 days.
Share Warrants
The Company grants share warrants at its discretion to
Directors, management, employees, advisors and lenders. These are
accounted for as equity settled transactions. Terms of warrants
vary from agreement to agreement.
Details for the warrants exercised, lapsed and outstanding at
the period ending 30 June 2021 are as follows:
Number of Weighted average exercise price (US$)
share warrants
Outstanding at 1 January 2021 3,994,165 0.09
Exercised during the period (928,089) 0.20
Forfeited during the period (11,947) 0.20
Outstanding at 30 June 2021 3,054,129 0.01
-------------------------------- ---------------- --------------------------------------
Exercisable at 30 June 2021 3,054,129 0.01
-------------------------------- ---------------- --------------------------------------
On 24 February 2021, 61,563 new ordinary shares were issued in
the Company following the exercise of warrants at an exercise price
of 15 pence per warrant. On 25 March 2021, the Company issued a
further 358,713 new ordinary shares following an exercise of
warrants at an exercise price of 15 pence per warrant. On 16 April
2021 and 17 May 2021, an additional 467,733 and 40,080,
respectively, new ordinary shares were issued in the Company
following the exercise of warrants at an exercise price of 15 pence
per warrant.
The weighted average contractual life of the share warrants
outstanding at the reporting date is 2 years and 122 days.
7. Events after the reporting period
On 7 July 2021, the Company granted options over a total of
5,250,000 ordinary shares of GBP 0.00037 each in the capital of the
Company to certain Directors and employees of the Company. The
options vest over four years and have an exercise price of 93 pence
per share.
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END
IR BUGDCIBGDGBB
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