POLX Polarean Imaging Plc

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, RUSSIA, 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, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"). 

PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.

22 May 2024                                                                                                                                                     

Polarean Imaging plc

("Polarean" or the "Company")

Result of Placing and Subscription

PDMR Dealings

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of lung function, announces, further to the announcement made on 21 May 2024 (the "Launch Announcement"), the successful completion of the Placing, which together with the Subscription, has raised gross proceeds of US$10 million (£8 million) by means of a placing to institutional and other investors (the "Placing") and a direct subscription with the Company (the "Subscription") of, in aggregate, 790,768,532 New Ordinary Shares at a price of 1 pence per New Ordinary Share (the "Issue Price").

The Subscription included an investment from existing investors NUKEM Isotopes GmbH ("NUKEM") and Bracco Imaging S.p.A. ("Bracco") and certain Directors and Management of the Company, as follows:

·    NUKEM, a leading global supplier of Xenon-129 and current 10.4 per cent owner of the Company's existing issued ordinary share capital (the "Existing Share Capital"), subscribed for 196,718,731 New Ordinary Shares at the Issue Price, representing an investment of US$2.5 million;

·    Bracco, the world-leading diagnostic imaging provider and current 7.6 per cent owner of the Company's Existing Share Capital, subscribed for 157,374,985 New Ordinary Shares at the Issue Price, representing an investment of US$2 million; and

·    Certain Directors and Management of the Company have subscribed for, in aggregate, 25,258,678 New Ordinary Shares at the Issue Price representing a total investment of approximately US$321,000.

The net proceeds of the Placing and Subscription, which are estimated to be approximately US$9 million will be used to accelerate commercialisation of XENOVIEW^TM, to support the continued investment in research and development including, amongst other developments, finalisation of the FDA plan to expand indications to gas exchange, to support efforts to continue to develop strategic partnerships and to provide additional working capital and for general corporate purposes.

The exchange rate used in relation to the Fundraise is £1.00 = US$1.27, unless otherwise stated, being the closing rate on 20 May 2024, being the latest practicable date prior to the date of the launch announcement.

Christopher von Jako, Chief Executive Officer of Polarean, commented: "We are delighted to announce today's successful Placing and Subscription of $10 million. We express our gratitude to our existing shareholders who have reaffirmed their support in this transaction, including NUKEM Isotopes GmbH and Bracco Imaging S.p.A. Notably, we have also been able to attract demand from new investors in this transaction, which will allow us to significantly broaden our shareholder register. The net proceeds of the Fundraise will enable the Company to substantially progress implementation of its five-pillar growth strategy in pursuit of its mission to revolutionise pulmonary medicine."

In addition, in order to provide Shareholders who have not taken part in the Placing or Subscription with an opportunity to participate in the proposed issue of New Ordinary Shares, the Company is providing Qualifying Shareholders with the opportunity to subscribe for an aggregate of approximately 200,000,000 Open Offer Shares, to raise approximately £2 million (US$2.5 million) (before expenses), on the basis of:

9 Open Offer Shares for every 10 Existing Ordinary Shares held on the Record Date, at a price of 1 pence per Open Offer share

Shareholders subscribing for their full entitlement under the Open Offer may also request additional Open Offer Shares through the Excess Application Facility.

Further details of the Open Offer and the terms and conditions on which it is being made, including the procedure for application and payment, will be contained in the Circular, extracts of which were contained in the Launch Announcement and which is expected to be posted to Shareholders on 23 May 2024. The Circular will also be available on the Company's website: https://www.polarean-ir.com/content/investors/shareholder-information.

Assuming completion of the Placing, Subscription and take-up of the Open Offer Shares in full, the Enlarged Share Capital is expected to be approximately 1,207,032,781 Ordinary Shares. On this basis, the New Ordinary Shares will represent approximately 82.1 per cent. of the Enlarged Share Capital.

Stifel is acting as Nominated Adviser and Sole Corporate Broker in connection with the Fundraise and Admission and Sole Bookrunner to the Company in connection with the Placing.

Director & PDMR Dealings and Shareholder Interests and Related Party Disclosure

Directors and Management of Polarean have subscribed for new Ordinary Shares in the amounts set out in the table below pursuant to the Subscription.

(1) Assuming full take up of all Open Offer Shares available under the Open Offer

NUKEM, which holds, as at the date of this announcement, directly or indirectly, 10.4 per cent. of the existing issued share capital of the Company, and Bracco, which holds approximately 7.6 per cent. of the existing issued share capital of the Company, are participating in the Fundraise at the Issue Price as follows:

(1) Assuming full take up of all Open Offer Shares available under the Open Offer and that NUKEM and Bracco only participate in the Subscription and not the Open Offer.

The participations by NUKEM, Bracco, Amati Global Investors and the Directors who are participating in the Transaction constitute related party transactions for the purposes of the AIM Rules. The Independent Director considers, having consulted with Stifel, the Company's nominated adviser, that the terms of the participation of those related parties in the Fundraise to be fair and reasonable insofar as shareholders of the Company are concerned.

Details of the Placing

The Company has raised US$5 million (£4 million) through a Placing, as follows:

·    US$2 million (£2 million), before expenses, through the placing of 179,590,124 EIS/VCT Placing Shares issued to investors seeking to invest in "eligible shares" for the purposes of EIS/VCT relief, conditional on, among other things, the passing by Shareholders of the Resolutions at the General Meeting

·    US$3 million (£2 million), before expenses, through the placing of 231,826,014 General Placing Shares conditional on, inter alia, the passing by Shareholders of the Resolutions at the General Meeting 

​

TIMETABLE OF PRINCIPAL EVENTS

Notes:

1.  Each of the times and dates above are indicative only and if any of the details contained in the timetable above should change, the revised times and dates will be notified to Shareholders by means of an announcement through a Regulatory Information Service.

2.  All of the above times refer to London time unless otherwise stated.

3.  All events listed in the above timetable following the General Meeting are conditional on the passing at the General Meeting of the Resolutions.

The timetable and the capitalised terms used in this announcement have the same meanings as in the Launch Announcement, unless otherwise stated.

Enquiries:

For the purposes of MAR and Article 2 of Commission Implementing Regulation (EU) 2016/1055, the person responsible for arranging for the release of this Announcement on behalf of the Company is Christopher von Jako, Chief Executive Officer.

About Polarean

Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercialising innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit www.polarean.com.

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

Notification and public disclosure of transactions by persons discharging managerial responsibilities ("PDMRs")

IMPORTANT NOTICES AND DISCLAIMER

This announcement (the "Announcement") and the information contained in it is not for publication, release, transmission distribution or forwarding, in whole or in part, directly or indirectly, in or into Australia, Canada, Japan, the Republic of South Africa or the United States or any other jurisdiction in which publication, release or distribution would be unlawful. This Announcement is for information purposes only and does not constitute an offer to sell or issue, or the solicitation of an offer to buy, acquire or subscribe for shares in the capital of the Company in Australia, Canada, Japan, the Republic of South Africa or the United States or any other state or jurisdiction where to do so would be unlawful. Any failure to comply with these restrictions may constitute a violation of the securities laws of such jurisdictions.  This Announcement has not been approved by the London Stock Exchange or by any other securities exchange. 

The New Ordinary Shares have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "Securities Act") or with any securities regulatory authority of any state or other jurisdiction of the United States and may not be offered, sold, pledged, taken up, exercised, resold, renounced, transferred or delivered, directly or indirectly, in or into the United States absent registration under the Securities Act, except pursuant to an exemption from the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States.  The New Ordinary Shares have not been approved, disapproved or recommended by the U.S. Securities and Exchange Commission, any state securities commission in the United States or any other U.S. regulatory authority, nor have any of the foregoing authorities passed upon or endorsed the merits of the offering of the New Ordinary Shares. Subject to certain exceptions, the securities referred to herein may not be offered or sold in in Australia, Canada, Japan, the Republic of South Africa or the United States or to, or for the account or benefit of, any national, resident or citizen in Australia, Canada, Japan, the Republic of South Africa or the United States.  No public offering of securities is being made in the United States.

No public offering of the New Ordinary Shares is being made in the United States, United Kingdom or elsewhere. All offers of the New Ordinary Shares will be made pursuant to an exemption under the UK version of the Prospectus Regulation (EU) 2017/1129, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "Prospectus Regulation") from the requirement to produce a prospectus. As a result, no prospectus will be made available in connection with the matters contained in this Announcement and no such prospectus is required (in accordance with the Prospectus Regulation) to be published. This Announcement and the terms and conditions set out herein are for information purposes only and are directed only at persons who have been selected by Stifel and who are: (a) persons in member states of the European Economic Area who are "qualified investors" within the meaning of Article 2(e) of Regulation (EU) 2017/1129 (together with any implementing measure in such member states, the "EEA Prospectus Regulation"); (b) in the United Kingdom, "qualified investors" within the meaning of the UK version of the EEA Prospectus Regulation (the "UK Prospectus Regulation"), which forms part of UK law by virtue of the European Union Withdrawal Act 2018, who are persons who: (i) have professional experience in matters relating to investments and are "investment professionals" within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the "Order"); (ii) are persons falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations, etc.") of the Order; or (c) are persons to whom it may otherwise be lawfully communicated (all such persons together being referred to as "relevant persons"). This Announcement and the terms and conditions set out herein must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this Announcement relates is available only to relevant persons and will be engaged in only with relevant persons. This Announcement must not be acted or relied on by persons who are not relevant persons. Persons distributing this Announcement must satisfy themselves that it is lawful to do so.

This Announcement has been issued by, and is the sole responsibility of, the Company. No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the directors or the Company, or by any of its or their respective partners, employees, advisers, affiliates or agents as to or in relation to, the accuracy or completeness of this Announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed.

This Announcement contains inside information for the purposes of Article 7 of MAR, encompassing information relating to the Fundraise described above, and is disclosed in accordance with the Company's obligations under Article 17 of 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, upon publication of this Announcement, those persons that received such inside information in a market sounding are no longer in possession of such inside information relating to the Company and its securities.

Stifel Nicolaus Europe Limited, which is authorised and regulated in the United Kingdom by the FCA, is acting as Nominated Adviser and Corporate Broker in connection with the proposed Placing, Open Offer and Admission and Sole Bookrunner to the Company in connection with the proposed Placing. Persons receiving this Announcement should note that Stifel Nicolaus Europe Limited is not acting for anyone other than the Company (including a recipient of this Announcement) and will not be responsible to anyone other than the Company for providing the protections afforded to clients of Stifel Nicolaus Europe Limited or for advising any other person in respect of the proposed Placing, Subscription and Open Offer and Admission or any transaction, matter or arrangement referred to in this Announcement. Stifel Nicolaus Europe Limited has not authorised the contents of, or any part of, this document and no liability whatsoever is accepted by Stifel Nicolaus Europe Limited, for the accuracy of any information or opinions contained in this Announcement or for the omission of any information, nor does it make any representation or warranty, express or implied, as to the accuracy of any information or opinions contained in this Announcement or for the omission of any information. Stifel Nicolaus Europe Limited expressly disclaims all and any responsibility or liability whether arising in tort, contract or otherwise which it might otherwise have in respect of this Announcement. Stifel Nicolaus Europe Limited, as nominated adviser and broker to the Company, owes certain responsibilities to the London Stock Exchange which are not owed to the Company or the Directors.

This Announcement includes 'forward-looking statements' which include all statements other than statements of historical facts, including, without limitation, those regarding the Company's financial position, business strategy, plans and objectives of management for future operations, or any statements preceded by, followed by or that include the words 'targets', 'believes', 'expects', 'aims', 'intends', 'will', 'may', 'anticipates', 'would', 'could' or 'similar' expressions or negatives thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Company's control that could cause the actual results, performance or achievements of Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. These forward-looking statements speak only as at the date of this Announcement. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based unless required to do so by applicable law or the AIM Rules.

This Announcement does not identify or suggest, or purport to identify or suggest, all of the risks (direct or indirect) that may be associated with an investment in the Fundraise. This Announcement does not constitute a recommendation concerning any investor's decision to purchase or subscribe for Ordinary Shares. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this Announcement and publicly available information. The price and value of securities can go down as well as up. Past performance is not a guide to future performance.   Any investment decision to subscribe for New Ordinary Shares must be made solely on the basis of publicly available information, which has not been independently verified. 

The information in this Announcement may not be forwarded or distributed to any other person and may not be reproduced in any manner whatsoever. Any forwarding, distribution, reproduction or disclosure of this information in whole or in part is unauthorised.

Neither the content of the Company's website nor any website accessible by hyperlinks on the Company's website is incorporated in, or forms part of, this Announcement.

Information to Distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the New Ordinary Shares have been subject to a product approval process, which has determined that the New Ordinary Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the New Ordinary Shares may decline and investors could lose all or part of their investment; the New Ordinary Shares offer no guaranteed income and no capital protection; and an investment in the New Ordinary Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Placing or the Open Offer. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Stifel will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the New Ordinary Shares.

Each distributor is responsible for undertaking its own Target Market Assessment in respect of the New Ordinary Shares and determining appropriate distribution channels.