polarean Regulatory News (POLX)

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, RECOMMENDATION, 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 £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 £8.4 million (US$10.7 million) (before expenses) by way of the issue of, in aggregate, 46,624,997 ordinary shares of £0.00037 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:

· £8.4 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 of 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.

"The 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 £2.2 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 €1.5 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 £7,991,414 (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 129Xenon 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 (£8.69 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 £8.4 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:

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:

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.

**ENDS**

Enquiries:

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 129Xenon 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 (129Xe) as an imaging agent to visualize ventilation.129Xe 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 129Xe 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 129Xe in MRI equipment for use as a medical diagnostic as well as a method of monitoring the efficacy of therapeutic intervention.