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Oslo, Norway, 23 September 2020
Nordic Nanovector ASA (OSE: NANO) (“Nordic Nanovector” or the “Company”), a
biopharmaceutical company dedicated to extending and improving the lives of
patients with haematological cancers through the development and
commercialisation of innovative targeted therapeutics, announces the launch of a
private placement of new shares (the “Offer Shares”) representing up to
approximately 20% of the outstanding share capital of the Company at this date
(the “Private Placement”). The Company has engaged ABG Sundal Collier ASA,
Carnegie AS and DNB Markets, a part of DNB Bank ASA as Joint Global Coordinators
and Joint Bookrunners (collectively referred to as the “Managers”) in connection
with the Private Placement.
Nordic Nanovector intends to use the net proceeds from the Private Placement for
the following purposes:
· 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 NOK 30 - 40 million per
month thereafter. There will be a need to secure further financing, through
equity, debt and/or partnerships, no later than during H1 2021 in order to
ensure sufficient financing for the Company to reach its major value inflection
point, the 3-month top-line data from the PARADIGME clinical study, targeted for
H2 2021.
Company update
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 26 August 2020 targeting 3
-month top-line data in H2’2021. Protocol amendments to PARADIGME being
implemented to enlarge eligible patient population and increase rate of
enrolment, decision based on reviewed FDA discussions:
·
·
· 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 February
2020
Nordic Nanovector believes that these initiatives make the Company well
positioned towards the read out from Phase IIb PARADIGME trial of Betalutin®.
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 24 September 2020 (the “Application
Period”). The Company and the Managers reserve the right to close or extend the
Application Period at any time and for any reason. If the Application Period is
shortened or extended, any other dates referred to herein may be amended
accordingly. The Company’s largest shareholder, HealthCap VI L.P., has pre
-subscribed for a number of Offer Shares equivalent to EUR 700,000. Primary
insiders including Chairman of the Board and key management have pre-subscribed
for a number of Offer Shares equivalent to approximately EUR 55,000.
The minimum subscription and allocation amount in the Private Placement will be
the NOK equivalent of EUR 100,000, provided that the Company may, at its sole
discretion, allocate an amount below EUR 100,000 to the extent applicable
exemptions from the prospectus requirement pursuant to applicable regulations,
including the Norwegian Securities Trading Act and ancillary regulations, are
available. Allocation of the Offer Shares will be determined at the end of the
book building process, and the final allocation will be made by the Company’s
Board of Directors (the “Board”) at its sole discretion, following advice from
the Managers.
The Offer Shares will be issued based on an authorisation granted to the
Company’s Board at the Company’s annual general meeting on 10 June 2020 (the
“Authorisation”).
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
24 September 2020 through a notification to be issued by the Managers.
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, HealthCap VI L.P. has agreed with the Managers to a lock-up for a
period of 90 days from the closing date, subject to customary exceptions.
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 Oslo Stock Exchange
tomorrow, 24 September 2020. Completion of the Private Placement is subject to
final approval by the Company’s Board.
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:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
Email: nordicnanovector@citigatedewerogerson.com
About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative therapies to
patients to address major unmet medical needs and advance cancer care. The
Company aspires to become a leader in the development of targeted therapies for
haematological cancers. Nordic Nanovector’s lead clinical-stage candidate is
Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to
advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with
substantial unmet medical need, representing a growing market forecast to be
worth nearly USD 29 billion by 2026. Nordic Nanovector retains global marketing
rights to Betalutin® and intends to actively participate in the
commercialisation of Betalutin® in the US and other major markets.
Further information can be found at www.nordicnanovector.com.
Important Notices
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 the United States of
America, Canada, Australia or Japan and it does not constitute an offer or
invitation to subscribe for or purchase any securities in such countries or in
any other jurisdiction. In particular, the document and the information
contained herein should not be distributed or otherwise transmitted into the
United States of America or to U.S. persons (as defined in the U.S. Securities
Act of 1933, as amended (the “Securities Act”) or to publications with a general
circulation in the United States of America. This document is not an offer for
sale of securities in the United States of America. The securities referred to
herein have not been and will not be registered under the Securities Act, or the
laws of any state, and may not be offered or sold in the United States of
America absent registration under or an exemption from registration under the
Securities Act. Nordic Nanovector does not intend to register any part of the
Private Placement in the United States of America.
There will be no public offering of the securities in the United States of
America. Any public offering in the United States of America would be made by
means of a prospectus containing detailed information about the company and
management, as well as financial statements.
The information contained herein does not constitute an offer of securities to
the public in the United Kingdom. No prospectus offering securities to the
public will be published in the United Kingdom. This document is only being
distributed to and is only directed at (i) persons who are outside the United
Kingdom or (ii) to investment professionals falling within article 19(5) of the
Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the
“Order”) or (iii) high net worth entities, and other persons to whom it may
lawfully be communicated, falling within article 49(2)(a) to (d) of the Order
(all such persons together being referred to as “relevant persons”). The
securities are only available to, and any invitation, offer or agreement to
subscribe, purchase or otherwise acquire such securities will be engaged in only
with, relevant persons.
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.
The Managers are acting for the Company in connection with the Private Placement
and no one else and will not be responsible to anyone other than the Company for
providing the protections afforded to their respective clients or for providing
advice in relation to the Private Placement or any transaction or arrangement
referred to in this press release.
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 © 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.
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 securities.
Each distributor is responsible for undertaking its own target market assessment
in respect of the securities and determining appropriate distribution channels.
This publication may contain specific forward-looking statements, e.g.
statements including terms like “believe”, “assume”, “expect”, “forecast”,
“project”, “may”, “could”, “might”, “will” or similar expressions. Such forward
-looking statements are subject to known and unknown risks, uncertainties and
other factors which may result in a substantial divergence between the actual
results, financial situation, development or performance of Nordic Nanovector
and those explicitly or implicitly presumed in these statements. Against the
background of these uncertainties, readers should not rely on forward-looking
statements. Nordic Nanovector assumes no responsibility to update forward
-looking statements or to adapt them to future events or developments.
Kilde
https://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX:32014R0596
