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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.
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.
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