Nordic Nanovector launches a private placement of new shares
- Further progress the pivotal PARADIGME Phase 2b trial with Betalutin® in patients with 3rd-line relapsed/refractory Follicular Lymphoma (3L R/R FL).
- Conduct Pharmacokinetics (PK) studies and execute CMC activities required for the planned BLA (Biological License Application) filing.
- Initiate the preparatory activities for the confirmatory phase 3 trial.
- General corporate purposes.
The proceeds from the Private Placement is expected to extend the Company's cash runway into Q3 2021, with an estimated burn rate of
The Company is carrying out the PARADIGME study, which investigates Betalutin® in relapsed/refractory non-Hodgkins lymphoma. The Company has in 2020 completed a strategic review and concluded that it will focus its efforts and resources fully on the PARADIGME study until its completion. Further, the Company has in 2020 made the following key decisions related to Betalutin® and the PARADIGME study:
- Expansion of inclusion criteria for recruitment to the PARADIGME trial
- Evaluating the use of single agent Betalutin® in relapsed/refractory Marginal Zone Lymphoma (MZL). Fast track (US) and Orphan drug (EU) designations achieved
- Focus for the PARADIGME trial going forward is set on the "40/15" arm based on Independent Review Committee recommendation (after comprehensive review of interim data)
The pivotal Phase IIb PARADIGME trial of Betalutin® in 3L R/R FL is, although significantly affected by COVID-19, progressing with 95 sites in 24 countries open for enrolment and 56/130 patients enrolled as of
- The Company has initiated the work towards the relevant regulators in each of the 24 countries in order to amend the protocol (inclusion criteria) and the Company expect to provide an update on this work in its Q3 2020 presentation scheduled for
19 November 2020
- The background for the amendment of the protocol is to speed up recruitment rates and the Company expect to be in position to provide further details in this respect no later than in its Q4 2020 presentation in
The Private Placement
The subscription price and the number of shares to be issued in the Private Placement will be determined through an accelerated book building process. The application period for the Private Placement commence today at 16:30 hours CEST and will close at 08:00 hours (CEST) on
The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of
The Offer Shares will be issued based on an authorisation granted to the Company's Board at the Company's annual general meeting on
The Board has considered alternative structures for the raising of new equity. Following careful considerations, the Board is of the view that it will be in the common interest of the Company and its shareholders to raise equity through a private placement setting aside the pre-emptive rights of the shareholders. By structuring the transaction as a private placement, the Company will be in a position to raise capital in an efficient manner, with a lower discount to the current trading price and with significantly lower risks compared to a rights issue. In addition, the Private Placement is subject to marketing through a pre-sounding and a publicly announced book building process. By this, a market based subscription price will be achieved. The Company will also consider whether to commence a repair offering towards the existing shareholders who did not participate in the Private Placement.
The Private Placement will be directed towards Norwegian and international investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. Notification of allotment and payment instructions is expected to be issued to the applicants on or about
The Private Placement is divided into two tranches:
- 6,850,350 shares will be settled with existing and unencumbered shares in the Company that are already listed on the
Oslo Stock Exchange, pursuant to share lending agreements between DNB Markets (on behalf of the Managers), the Company, HealthCap VI L.P.and Radiumhospitalets Forskningsstiftelse, in order to facilitate delivery of listed shares to investors on a delivery versus payment basis (the "Tranche 1 Offer Shares"). The Tranche 1 Offer Shares will be tradable from allocation. The Managers will settle the share loan with a corresponding number of new shares in the Company to be issued by the Board pursuant to the Authorisation, expected on or about 30 September 2020.
- The Managers are expected to pre-fund the subscription price for the remaining Offer Shares (the "Tranche 2 Offer Shares") to facilitate a swift registration of the share capital increase in the Norwegian Register of
Business Enterprises(the "NRBE"). The Tranche 2 Offer Shares will be tradable from registration of the share capital increase in the NBRE, expected to be on or about 25 September 2020. Delivery of the Tranche 2 Offer Shares will be on a delivery versus payment basis to the investors. The Tranche 2 Offer Shares will be issued by the Board pursuant to the Authorisation.
The Company has agreed with the Managers to a lock-up on future share issuances for a period of 90 days from the closing date, subject to customary exceptions. The Company's Board and Executive Management have all agreed with the Managers to a lock-up on existing shareholdings for a period of 360 days from the closing date, subject to customary exceptions. In addition, the Company's largest shareholder,
The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before opening of trading on the
The Company's latest company update presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/2020.
For further information, please contact:
Malene Brondberg, CFO
Cell: +44 7561 431 762
Tel: +44 203 926 8535
Further information can be found at www.nordicnanovector.com.
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This document is not an offer to sell or a solicitation of offers to purchase or subscribe for shares. Copies of this document may not be sent to jurisdictions, or distributed in or sent from jurisdictions, in which this is barred or prohibited by law. The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, in any jurisdiction in which such offer or solicitation would be unlawful absent registration, or an exemption from registration or qualification under the securities laws of any jurisdiction.
This document is not for publication or distribution in
There will be no public offering of the securities in
The information contained herein does not constitute an offer of securities to the public in the
Any person who is not a relevant person should not act or rely on this document or any of its contents. Any offer of securities to the public that may be deemed to be made pursuant to this communication in any member state of the European Economic Area (each an "EEA Member State") that has implemented Regulation 2017/1129 (the "Prospectus Regulation") is only addressed to qualified investors in that Member State within the meaning of the Prospectus Regulation.
The information contained in this document does not purport to be comprehensive. None of the Managers, any of their respective subsidiary undertakings or affiliates, or their respective directors, officers, employees, advisers or agents accepts any responsibility or liability whatsoever for (whether in contract, tort or otherwise) or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this document (or whether any information has been omitted from the document) or any other information relating to the Company, its subsidiaries, affiliates or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this document or its contents or otherwise arising in connection therewith. The Managers disclaim any responsibility for any acts or omissions of the Company, any of the Directors, or any other person in connection with the Private Placement.
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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 securities described in this press release have been subject to a product approval process, which has determined that such securities 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 securities may decline and investors could lose all or part of their investment; the securities offer no guaranteed income and no capital protection; and an investment in the securities 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 Transaction. Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Managers will only approach investors who meet the criteria of professional clients and eligible counterparties.
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