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02 Nov 2024

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FluoGuide develops surgical solutions that is expected to reduce suffering for the patient and increases the likelihood of cure as well as reducing costs for the health care system.

New - New exchange: Nasdaq First North

FluoGuide is moving from Spotlight to Nasdaq First North. Shareholders are strongly encouraged to make sure they will be able to freely trade their shares in the future.

FluoGuide intends to carry out a directed share issue of approximately SEK 25 million

Press release


March 10, 2022

Copenhagen, Denmark, 17:31 CEST, 10 March 2022 – FluoGuide A/S (publ), a developer of surgical precision solutions within oncology (“FluoGuide” or the “Company”) (Nasdaq First North Growth Market: FLUO) hereby announces its intention to carry out a directed share issue of approximately SEK 25 million to Swedish and international institutional investors (the “Directed Share Issue”). The Company has appointed ABG Sundal Collier to act as Sole Bookrunner (the “Bookrunner”) in connection with the Directed Share Issue.

The subscription price and the total number of new shares in the Directed Share Issue will be determined by way of an accelerated bookbuilding procedure (the “Bookbuilding”). The Company believes that using the flexibility provided by the Directed Share Issue is the most appropriate alternative for the Company at this time, allowing it to raise capital in a timely and cost-effective manner and to diversify the shareholder base. By establishing the subscription price in the Directed Share Issue through an accelerated bookbuilding procedure, it is the assessment of the board of directors that the subscription price will accurately reflect current market conditions and demand.

The Bookbuilding will start immediately following this announcement. Pricing and allocation of the new shares in the Directed Share Issue is expected to take place before beginning of trading on Nasdaq First North Growth Market Stockholm at 09:00 CEST on 11 March 2022. The exact timing of closing of the Bookbuilding, pricing and allocation is at the discretion of the Company and the Bookrunner. The Company will announce the outcome of the Directed Share Issue immediately after closing of the Bookbuilding in a subsequent press release.

The net proceeds of the Directed Share Issue are intended to co-finance a phase II study in less aggressive brain cancers (meningioma and low grade glioma) and provide flexibility post the two phase II results for using FG001 guide surgery of high grade glioma and lung cancer. The phase III program for FG001 in brain cancer is planned to be initiated in 2023.

Consummation of the Directed Share Issue is, among other things, subject to a resolution by the board of directors of FluoGuide to issue new shares, pursuant to the authorization given by annual general meeting on 9 February 2021, following closing of the Bookbuilding.

In connection with the Directed Share Issue, the Company, Morten Albrechtsen (through Wexotec ApS) and Andreas Kjaer (through Life Science ApS), have agreed pursuant to a lock-up undertaking, subject to customary exceptions, not to issue or sell additional shares for a period of 90 days following settlement of the Directed Share Issue.

For more information contact:

FluoGuide A/S

Morten Albrechtsen, CEO
+45 24 25 62 66
ma@fluoguide.com

Henrik Moltke, CFO
+45 22 44 54 04
hm@fluoguide.com

Certified adviser:
Svensk Kapitalmarknadsgranskning AB
+46 70 755 95 51
ca@skmg.se

About FluoGuide

FluoGuide’s primary focus is to maximize surgical outcomes in oncology. The Company’s lead product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved precision enabled by FluoGuide’s products has a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company is has demonstrated early evidence of efficacy of F001 as well as it to be well tolerated and safe in the ongoing proof-of-concept clinical study (phase I/II) in patients with high grade glioma undergoing surgery. FluoGuide is listed on Nasdaq First North Sweden under the ticker “FLUO”.

Important information

Publication, distribution or release of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in the Company in any jurisdiction, neither from FluoGuide nor from anyone else.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the new shares. Any investment decision in connection with the Directed Share Issue must be made on the basis of all publicly available information relating to the Company and the Company’s shares. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness.

This announcement does not constitute a recommendation concerning any investor’s option with respect to the Directed Share Issue. 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.

This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be published, distributed or released, directly or indirectly, in whole or in part, within or into the United States of America, Australia, Canada, Hong Kong, Israel, Japan, New Zeeland, South Africa, Switzerland or in any other jurisdiction where such publication, distribution or release of the information would not comply with applicable laws and regulations or would require prospectuses, registration or any other measures than those required by Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

This press release is not a prospectus for the purposes of Regulation 2017/1129 of the European parliament and of the council (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. FluoGuide has not authorized any offer to the public of shares or other securities in the United Kingdom or any member state of the EEA and no prospectus has been or will be prepared in connection with the Directed Share Issue. In any EEA Member State, this communication is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of the Prospectus Regulation.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” within the meaning of the Prospectus Regulation who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, Relevant Persons. Persons who are not Relevant Persons should not take any action on the basis of this press release and should not act or rely on it.

This press release may contain forward-looking statements which reflect FluoGuide’s current view on future events and financial and operational development. Words such as “intend”, “expect”, “anticipate”, “may”, “believe”, “plan”, “estimate” and other expressions which imply indications or predictions of future development or trends, and which are not based on historical facts, are intended to identify forward-looking statements. Forward-looking statements inherently involve both known and unknown risks and uncertainties as they depend on future events and circumstances. Forward-looking statements do not guarantee future results or development and the actual outcome could differ materially from the forward-looking statements.

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 amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; 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 shares in the Directed Share Issue (the “Issue Shares”) have been subject to a product approval process, which has determined that the Issue 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 Issue Shares may decline and investors could lose all or part of their investment; the Issue Shares offer no guaranteed income and no capital protection; and an investment in the Issue 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 Directed Share Issue. Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Joint Bookrunners 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 Issue Shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Issue Shares and determining appropriate distribution channels.