TIDMPOLX
RNS Number : 1279G
Polarean Imaging PLC
13 March 2020
THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS
RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN
WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM
AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA OR THE
UNITED STATES OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE,
PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.
THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT
CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMATION,
OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE
OR DISPOSE OF ANY SECURITIES IN POLAREAN IMAGING PLC OR ANY OTHER
ENTITY IN ANY JURISDICTION.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 ("MAR"). In addition,
market soundings (as defined in MAR) were taken in respect of the
Placing with the result that certain persons became aware of inside
information (as defined in MAR), as permitted by MAR. This inside
information is set out in this announcement. Therefore, those
persons that received inside information in a market sounding are
no longer in possession of such inside information relating to the
Company and its securities.
Polarean Imaging Plc
("Polarean" or the "Company")
Conditional Fundraise to raise GBP 8.4 million
Notice of General Meeting
Polarean Imaging plc (AIM: POLX), a clinical stage medical
imaging technology company developing a proprietary magnetic
resonance imaging (MRI) drug-device combination, announces that it
has conditionally raised a total of GBP8.4 million (US$10.7
million) (before expenses) by way of the issue of, in aggregate,
46,624,997 ordinary shares of GBP0.00037 each in the capital of the
Company (the "Fundraise Shares").
The Fundraise (as defined below) follows the positive top-line
results from the Company's pivotal phase III Clinical Trials which
were announced on 29 January 2020. The net proceeds of the
Fundraise will strengthen the Company's balance sheet while it
focusses on preparing its New Drug Application (NDA), which is
planned for submission to the U.S. Food and Drug Administration
(FDA) during the third quarter of 2020.
Highlights:
-- GBP8.4 million (US$10.7 million) (before expenses) to be
raised by means of a conditional fundraise (the "Fundraise") and
the issue of, in aggregate 46,624,997 Fundraise Shares at 18 pence
per Fundraise Share (the "Fundraise Price").
-- Funds to be deployed to support the preparation and
submission of the NDA, support the initial preparation for
commercial launch following submission of the NDA, and to provide
additional working capital to build and sell additional
polarisers.
-- Fundraise supported by new and existing Institutional
investors as well as a new strategic investor, Bracco Imaging
S.p.A. ("Bracco"), a world-leading diagnostic imaging provider and
part of the Bracco group of companies.
-- The Fundraise comprises a conditional placing (the
"Placing"), which was undertaken by the Company's broker SP Angel
Corporate Finance LLP and a conditional subscription (the
"Subscription") for Fundraise Shares, details of which are set out
below.
-- The Fundraise will be subject to Polarean's shareholders
approving resolutions to increase the Directors' authority to allot
the Fundraise Shares, and to disapply statutory pre-emption rights,
at a General Meeting (the "Resolutions").
-- A Circular which sets out details of the conditional
Fundraise and also includes a Notice of General Meeting will be
sent to shareholders later today (the "Circular"). The General
Meeting is to be held at the offices of Reed Smith LLP at The
Broadgate Tower, 20 Primrose Street, London, EC2A 2RS at 2.00 p.m.
on 1 April 2020.
-- Directors and certain other Shareholders have irrevocably
undertaken to vote in favour of the Resolutions, in respect of
their shares, representing 31.7 per cent of the Existing Ordinary
Shares.
Richard Hullihen, Chief Executive Officer o f Polarean, said:
"We are extremely grateful for the ongoing support from our
existing shareholders and along with some new institutions, we are
delighted to welcome Bracco, a world leader in diagnostic imaging,
to our shareholder register.
"T he positive results from our Clinical Trials provide us with
a solid platform from which to prepare our NDA submission to the
FDA. We are excited about the opportunity to commericialise our
technology which allows clinicians to uniquely visualise aspects of
lung function, which have never before been visible by MRI, both
safely and quantitatively and I look forward to providing
shareholders with further updates as we embark on the next stage of
Polarean's development."
Fulvio Renoldi Bracco, Chief Executive Officer of Bracco
Imaging, said : "This investment is part of our strategy to support
the advancement of unique diagnostic technologies, such as
Polarean's, to address unmet medical needs".
The Circular, extracts of which are included below, will also be
available later today via the Company's website at:
http://www.polarean-ir.com/content/investors/shareholder-information.asp
Background to the Placing
Following the successful completion of the Clinical Trials, the
Company is focusing on preparing and submitting the NDA and
preparing for the commercial launch of the Company's drug-device
combination. The Group is undertaking the Fundraise at this time in
order to strengthen the Company's balance sheet while it prepares
for the submission of the NDA, which is currently expected during
the third quarter of 2020.
The Company also intends to continue to expand its IP portfolio
as it prepares for the marketing of its drug device platform ahead
of the commercial launch.
Strategic Investment by Bracco
The Company is pleased to announce that Bracco
(https://www.bracco.com), part of an international group of
companies focused on healthcare and a leader in diagnostic imaging,
has conditionally agreed to invest GBP2.2 million as part of the
Fundraise via the Subscription.
Bracco has entered into a Subscription Agreement with the
Company pursuant to which Bracco will subscribe for 12,222,222
Subscription Shares at the Fundraise Price. As such, following the
completion of the Fundraise, Bracco will own 7.6 per cent of the
Enlarged Share Capital.
In addition, following Admission and for so long as it holds at
least 7,000,000 Ordinary Shares, Bracco will have the right to
nominate one individual to be appointed as a non-executive Director
to the Board of the Company (the 'Bracco Director'). The Bracco
Director will be appointed to the Board on the same basis as
regards voting and term of appointment as the Company's existing
non-executive Directors. The Bracco Director will therefore be
subject to the same requirements as contained in the Articles of
Association of the Company for such appointment to be approved at
the next Annual General Meeting of the Company, and will be subject
to the same requirements for retirement by rotation as the other
Directors.
A further announcement regarding the appointment of the Bracco
Director will be made in due course.
Background to Bracco
Bracco, part of the Bracco group of companies, is a
world-leading diagnostic imaging provider, with 2019 revenues of
EUR1.5 billion. Headquartered in Milan, Italy, Bracco develops,
manufactures and markets diagnostic imaging agents and
solutions.
Bracco offers a product and solution portfolio for all key
diagnostic imaging modalities: X-ray imaging (including Computed
Tomography-CT, Interventional Radiology, and Cardiac
Catheterization), magnetic resonance imaging (MRI), Contrast
Enhanced Ultrasound (CEUS), and Nuclear Medicine through
radioactive tracers and novel PET imaging agents to inform clinical
management and guide care for cancer patients in areas of unmet
medical need. Bracco's continually evolving portfolio is completed
by a range of medical devices, advanced administration systems and
dose-management software. Bracco operates in over 100 markets
worldwide, either directly or indirectly, through subsidiaries,
joint ventures, licenses and distribution partnership agreements.
Bracco has a strong presence in key geographies: North America,
China, Europe, Japan, Brazil, Mexico and South Korea.
Use of Proceeds
The net proceeds of the Fundraise, which are estimated to be
GBP7,991,414 (US$10,187,048), will be used as follows:
-- to support the preparation and submission of the NDA;
-- to support the initial preparation for commercial launch
following the submission of the NDA by creating awareness of
hyperpolarised (129) Xenon MRI as a diagnostic tool for targeted
physicians and potential strategic partners . This will include,
but will not be limited to:
o an expanded schedule of participation in clinical and
scientific conferences and meetings in pulmonary and cardiovascular
medicine; and
o consultancy expenditure on the Company's reimbursement and
drug pricing strategies; and
-- to provide additional working capital to build and sell additional polarisers.
The Company will require further capital in order to execute its
longer-term strategy which includes the commercial launch of its
technology in new jurisdictions, including Europe. The Board will
therefore continue to explore additional funding options, including
strategic partnerships, non-dilutive government funding from grants
and further issues of Ordinary Shares, subject to the Directors
being satisfied with the issue price of these shares at the
time.
Current PROSPECTS and Outlook
Polarean is currently trading in line with market expectations.
The audit for the year ended 31 December 2019 is now underway, with
the full year revenue for 2019 expected to be approximately US$2.3
million (2018: US$2.4 million), the unaudited adjusted EBITDA loss
approximately US$5.2 million (2018: US$4.8 million) and unaudited
loss after tax for the year of US$6.0 million (2018: US$5.4
million). Following the completion of the Fundraise, the Group will
have cash of around US$11.087 million (GBP8.69 million).
The Group expects to release its audited results for the year
ended 31 December 2019 by the end of May 2020.
The Directors expect the Company to continue generating revenue
from the sale of its polarisers throughout the year ahead, with a
minimum of three sales expected before the end of 2020.
DETAILS OF the FUNDRAISE
The Company has conditionally raised GBP8.4 million (US$10.7
million), before expenses, by way of a conditional Placing to new
and existing institutional investors of 33,847,220 Placing Shares
and conditional Subscriptions by Bracco and Jonathan Allis for a
total of 12,777,777 Subscription Shares, in each case at the
Fundraise Price. Assuming the issue of all of the Fundraise Shares,
the Fundraise Shares will represent approximately 41 per cent. of
the Existing Ordinary Shares and will, when issued, represent
approximately 28.9 per cent. of the Enlarged Share Capital.
The Fundraise Shares will, following Admission, rank in full for
all dividends and distributions declared, made or paid in respect
of the issued Ordinary Share capital of the Company and otherwise
rank pari passu in all other respects with the Existing Ordinary
Shares.
Application will be made for the Fundraise Shares to be admitted
to trading on AIM as soon as practicable following the General
Meeting. Admission is currently expected to occur at 8.00a.m. on or
around 2 April 2020.
The Placing and the Placing Agreement
In connection with the Placing, the Company has today entered
into the Placing Agreement with SP Angel pursuant to which SP Angel
has agreed to act as agent for the Company and use its reasonable
endeavours to place the Placing Shares at the Fundraise Price with
certain new and existing institutional investors. The Placing is
conditional, among other things, upon: (i) the passing of the
Resolutions; and (ii) Admission occurring as soon as practicable
following the General Meeting or by such later time and/or date as
SP Angel and the Company may agree but not later than 8.00 am on 24
April 2020.
The Placing Agreement contains customary warranties from the
Company in favour of SP Angel in relation to (amongst other things)
the accuracy of the information in the Circular and other matters
relating to the Company and its business. In addition, the Company
has agreed to indemnify SP Angel in relation to certain liabilities
they may incur in undertaking the Placing. SP Angel has the right
to terminate the Placing Agreement in certain circumstances prior
to Admission. In particular, SP Angel may terminate in the event
that there has been a material breach of any of the warranties, the
conditions of the agreement have become incapable of fulfilment or
for force majeure. The Placing will not be underwritten.
The Placing Shares will represent approximately 21 per cent. of
the Enlarged Share Capital.
The Subscription
The Subscription Shares will be issued to the Subscribers, at
the Fundraise Price, by the Company pursuant to the Subscription
Agreements. The Subscription is conditional, amongst other things,
upon shareholder approval to issue the Subscription Shares being
granted at the General Meeting and Admission occurring as soon as
practicable following the General Meeting but not later than 8.00
am on the 24 April 2020.
The Subscription Shares will represent approximately 7.9 per
cent. of the Enlarged Share Capital.
DIRECTORS' AND OTHER INTERESTS
Jonathan Allis, the Company's Chairman has conditionally
subscribed for a total of 555,555 Fundraise Shares at the Fundraise
Price.
As at the date of this announcement and immediately following
Admission, the interests (all of which are beneficial unless
otherwise stated), whether direct or indirect, of the Directors and
their families in the issued share capital of the Company and the
existence of which is known to or could, with reasonable diligence,
be ascertained by that Director, are as follows:
Immediately following
Date of this announcement Admission
------------------- ---------------------------- ------------------------------
Percentage
No of issued of issued No of issued Percentage
Ordinary Ordinary Ordinary of Enlarged
Name Shares Shares Shares Share Capital
------------------- --------------- ----------- ------------- ---------------
Jonathan Allis 1,877,574 1.6 2,433,129 1.5
Richard Hullihen 2,928,899 2.6 2,928,899 1.8
Kenneth West 475,594 0.5 475,594 0.3
Bastiaan Driehuys 12,267,503 12.2 12,267,503 7.6
significant shareholders
Certain significant shareholders have also conditionally
subscribed for Fundraise Shares. As at the date of this
announcement and immediately following Admission, the Directors are
aware of the following persons who, directly or indirectly, are
interested in three per cent. or more of the Company's existing
Ordinary Share Capital before Admission and their resultant
holdings after Admission:
Immediately following
Date of this announcement Admission
------------------------ ---------------------------- ------------------------------
Percentage
No of issued of issued No of issued Percentage
Ordinary Ordinary Ordinary of Enlarged
Name Shares Shares Shares Share Capital
------------------------ --------------- ----------- ------------- ---------------
Amati Global Investors 12,460,318 10.9 23,571,429 14.6
Bastiaan Driehuys 12,267,503 10.7 12,267,503 7.6
NUKEM Isotopes Imaging
GmbH 11,234,208 9.8 11,234,208 7.0
W.B. Nominees Limited 8,227,335 7.2 8,316,224 5.2
John Sudol 7,542,121 6.6 7,542,121 4.7
Bracco 0 0 12,222,222 7.6
* The percentages shown are based on the most recent share register
analysis or latest date of notification
Related Party Transaction
Jonathan Allis and Amati are, respectively, a Director and
substantial shareholder in the Company and their participation in
the Fundraise constitutes a related party transaction in accordance
with AIM Rule 13. Richard Hullihen, Kenneth West, Bastiaan Driehuys
and Juergen Laucht who are not subscribing for Fundraise Shares and
are therefore considered to be independent Directors for these
purposes, having consulted with SP Angel, consider the terms of the
Related Parties' participation in the Fundraise to be fair and
reasonable insofar as the Shareholders are concerned.
Total Voting Rights
Following Admission, the Company will have a total of
161,295,607 Ordinary Shares in issue with each Ordinary Share
carrying the right of one vote. The above figure may be used by
shareholders as the denominator for the calculation by which they
will determine if they are required to notify their interest in, or
change to their interest in, the Company under the FCA's Disclosure
Guidance and Transparency Rules.
Unless otherwise indicated, all defined terms in this
announcement shall have the same meaning as described in the
Circular.
**S**
Enquiries:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Via Walbrook PR
Officer
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)7879
741 001
About Polarean's Technology
Polarean's technology produces hyperpolarized inert Xenon gas,
used in conjunction with standard MRI to create high-resolution
three-dimensional functional maps of the human lung. This technique
provides a unique and sensitive way to monitor changes in lung
structure and function; it is currently used in basic and clinical
research to study lung physiology and to monitor the efficacy of
new drugs.
The central equipment required for hyperpolarized gas MRI is a
polarizer. Using circularly polarized laser light, the polarizer
transforms the inert, stable noble gas isotope (129) Xenon into its
hyperpolarized state. This process leaves the gas chemically
unchanged, while only the nucleus is magnetically aligned. The
resulting MRI signal is enhanced by a factor of 100,000, making
direct imaging of gas atoms possible.
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
specializes in the use of hyperpolarized Xenon gas ((129) Xe) as an
imaging agent to visualize ventilation.(129) Xe gas is currently
being studied for visualization of 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 also develops and manufactures 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 optimize 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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCSFAFEDESSELD
(END) Dow Jones Newswires
March 13, 2020 08:51 ET (12:51 GMT)
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